Cannabidiol (CBD) powder formulation
T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate (Formulation 725: Water soluble.Contains sorbitol)
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According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body. In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-11-15
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Pharmacokinetics describes the speed in which something that is ingested is made available within the body (i.e. bioavailability).There are many different preparations/formulations of CBD and they may differ from one another with regards to their pharmacokinetics. One important consideration when evaluating CBD formulations is the pharmacokinetic goal and intended use. For example, if the indication for the CBD is to treat acute pain, then a faster time to peak concentration (Tmax) and higher maximal concentration (Cmax) may be desirable, and also may help to decrease the risk of overdose due to premature repeat self administration. Alternatively, as a chronic treatment for anxiety, a larger area under the curve (AUC) may be preferable if a user follows a regular dosing schedule. One purpose of the proposed project is to compare the pharmacokinetics of different formulations of CBD. The formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). Several previous studies have demonstrated an influence of eating on the pharmacokinetics of ingested CBD. The general consensus appears to be that prior ingestion of a high-fat meal increases the maximal concentration of circulating CBD (Cmax) and lowers the time to attain peak circulating concentration (Tmax). One purpose of the proposed project is to study the influence of a standardized meal on the pharmacokinetics of a CBD formulation. Little is known about the influence of ingested CBD on postprandial metabolism. The thermic effect of feeding (i.e. the increase in metabolic rate above resting metabolism) is considered an important physiological determinant of energy balance, and therefore also of weight gain or loss. Further, the dynamics of circulating glucose and triglycerides following a meal are reflective of metabolic health and predictive of future cardiometabolic disease risk. CBD has been purported to have a variety of beneficial physiological properties, including anti-inflammatory and antioxidant actions. Either of these individual properties alone could favorably modify postprandial metabolism, given that CBD potentially does both, it appears likely that CBD might improve the physiological regulation of postprandial metabolism. One purpose of the proposed project is to determine the influence of CBD on postprandial metabolism. The liver plays a critical regulatory role in postprandial metabolism, and also with the physiological processing of cannabinoids. The relationship between the use of cannabinoids and liver health is unclear. While early studies implied that exposure of the liver to very high daily dosing of cannabinoids may be detrimental, more recent studies are suggesting that some cannabinoids, including CBD, may have therapeutic potential for the treatment of non-alcoholic fatty liver disease. The acute effects of low dose CBD (e.g. 30 mg) on liver function in healthy adults have not been well described, and may be influenced by the formulation of the CBD product (i.e. whether it is water or lipid soluble). One purpose of the proposed project is to determine the acute influence of different formulations of CBD on circulating markers of liver function.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate (Formulation 725: Water soluble.Contains sorbitol)
30 mg CBD isolate in MCT oil,1:1 ratio of CBD to Medium Chain Triglycerides oil. (Formulation 088: Not water soluble. Contains medium chain triglyceride coconut oil.)
10% CBD Gum Arabic, maltodextrin base(Formulation 126: Water soluble. Contains gum arabic and maltodextrin)
10% CBD Gum Arabic, sorbitol base (Formulation 213: Water soluble. Contains gum arabic and sorbitol)
Pure CBD as crystalline powder (\>99% purity) (Formulation 625 Not water soluble)
Matching Placebo
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 088 | 12 | 116.3 | 76 |
| Formulation 126 | 14 | 35.4 | 13.5 |
| Formulation 213 | 14 | 51.8 | 24.2 |
| Formulation 625 | 11 | 129.5 | 89.6 |
| Formulation 725 | 14 | 38.2 | 24.9 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 088 | 12 | 0.5 | 0.2 |
| Formulation 126 | 14 | 3.1 | 2.1 |
| Formulation 213 | 14 | 2.2 | 2.0 |
| Formulation 625 | 11 | 0.4 | 0.6 |
| Formulation 725 | 14 | 1.8 | 1.5 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 088 | 12 | 62.8 | 29.7 |
| Formulation 126 | 14 | 272.3 | 176 |
| Formulation 213 | 14 | 208.6 | 151.1 |
| Formulation 625 | 11 | 46 | 59.4 |
| Formulation 725 | 14 | 177.3 | 104.8 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL).
Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 126 | 6 | 385.2 | 226.6 |
| Formulation 213 | 5 | 367.6 | 217.1 |
| Formulation 725 | 2 | 301.6 | 221.9 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 088 | 5 | 280.7 | 141.5 |
| Formulation 126 | 14 | 171.0 | 129.2 |
| Formulation 213 | 11 | 140.5 | 96.6 |
| Formulation 625 | 3 | 442.7 | 451.0 |
| Formulation 725 | 13 | 133.1 | 26.7 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h).
Population: Outcome measure not collected
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 088 | 5 | 00.003 | .001 |
| Formulation 126 | 14 | .006 | .003 |
| Formulation 213 | 11 | .006 | .002 |
| Formulation 625 | 3 | 0.003 | .002 |
| Formulation 725 | 13 | 0.005 | .001 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L).
Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 126 | 6 | 11836405 | 7642484 |
| Formulation 213 | 5 | 13130100 | 6339554 |
| Formulation 725 | 2 | 22687960 | 16435999 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 14 | 113.6 | 70.5 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 14 | 2.9 | 1.3 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 14 | 397 | 167 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL).
Population: Data not Collected
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 7 | 248.6 | 304.6 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h).
Population: Data not collected
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 7 | 0.005 | 0.002 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L).
Population: Data Not Collected
At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725.
Population: The thermic effect of feeding refers to the increase in energy expenditure after eating. On the X-axis, the independent variable is time, and the unit is minutes (min). On the Y-axis, the dependent variable is energy expenditure, and the unit is kilocalories per minute (kcal/min). Thus, the unit for area under the curve is kcal/min X min.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 14 | 58.83 | 14.3 |
| Placebo | 14 | 55.28 | 27.62 |
At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 13 | 18634.8 | 2651.8 |
| Placebo | 14 | 19001.72 | 4037.1 |
At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 13 | 7043.3 | 4780.8 |
| Placebo | 14 | 6934.75 | 4556.64 |
At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 10 | 24978.8 | 9538.7 |
| Placebo | 14 | 30605.36 | 17037.6 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 26.1 | 10.1 |
| Formulation 088 | 14 | 28 | 10.9 |
| Formulation 126 | 14 | 27.5 | 8.4 |
| Formulation 213 | 14 | 29 | 10.6 |
| Formulation 625 | 14 | 30.5 | 11.2 |
| Formulation 725 | 14 | 27.7 | 9.1 |
| Placebo | 14 | 26.9 | 10.8 |
| Formulation 088 | 14 | 27.9 | 10 |
| Formulation 126 | 14 | 29.3 | 8.1 |
| Formulation 213 | 14 | 29.1 | 9.8 |
| Formulation 625 | 14 | 30.4 | 11 |
| Formulation 725 | 14 | 27.3 | 8.7 |
| Placebo | 14 | 26.0 | 11.2 |
| Formulation 088 | 14 | 28.6 | 10.6 |
| Formulation 126 | 14 | 28.2 | 7.9 |
| Formulation 213 | 14 | 28.7 | 10.5 |
| Formulation 625 | 14 | 30.7 | 11.5 |
| Formulation 725 | 14 | 27.6 | 9.8 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 3.6 | 0.3 |
| Formulation 088 | 14 | 3.9 | 0.3 |
| Formulation 126 | 14 | 3.9 | 0.2 |
| Formulation 213 | 14 | 3.8 | 0.3 |
| Formulation 625 | 14 | 3.8 | 0.3 |
| Formulation 725 | 14 | 3.8 | 0.3 |
| Placebo | 14 | 3.6 | 0.2 |
| Formulation 088 | 14 | 3.8 | 0.3 |
| Formulation 126 | 14 | 3.8 | 0.3 |
| Formulation 213 | 14 | 3.8 | 0.2 |
| Formulation 625 | 14 | 3.8 | 0.2 |
| Formulation 725 | 14 | 3.8 | 0.2 |
| Placebo | 14 | 3.4 | 0.3 |
| Formulation 088 | 14 | 3.9 | 0.3 |
| Formulation 126 | 14 | 3.9 | 0.3 |
| Formulation 213 | 14 | 3.9 | 0.2 |
| Formulation 625 | 14 | 4.0 | 0.2 |
| Formulation 725 | 14 | 3.9 | 0.2 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 62.1 | 8.6 |
| Formulation 088 | 14 | 62.5 | 7.9 |
| Formulation 126 | 14 | 63.6 | 10.8 |
| Formulation 213 | 14 | 60.3 | 6.8 |
| Formulation 625 | 14 | 61.9 | 9.4 |
| Formulation 725 | 14 | 60.4 | 12 |
| Placebo | 14 | 62.9 | 9.8 |
| Formulation 088 | 14 | 60.5 | 7.2 |
| Formulation 126 | 14 | 61.9 | 11 |
| Formulation 213 | 14 | 61 | 8.7 |
| Formulation 625 | 14 | 61.6 | 9.3 |
| Formulation 725 | 14 | 60.9 | 11.4 |
| Placebo | 14 | 58.8 | 8.5 |
| Formulation 088 | 14 | 60.2 | 8.0 |
| Formulation 126 | 14 | 61.4 | 9.6 |
| Formulation 213 | 14 | 62.1 | 9.5 |
| Formulation 625 | 14 | 62.3 | 9.2 |
| Formulation 725 | 14 | 61 | 12.6 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 28.0 | 12.3 |
| Formulation 088 | 14 | 30.5 | 4.1 |
| Formulation 126 | 14 | 30.2 | 3.4 |
| Formulation 213 | 14 | 33.5 | 7 |
| Formulation 625 | 14 | 30.6 | 7.3 |
| Formulation 725 | 14 | 29.2 | 5 |
| Placebo | 14 | 30.7 | 10.4 |
| Formulation 088 | 14 | 30.6 | 4.6 |
| Formulation 126 | 14 | 29.4 | 8.7 |
| Formulation 213 | 14 | 30.9 | 5.1 |
| Formulation 625 | 14 | 31.4 | 7.4 |
| Formulation 725 | 14 | 28.9 | 4.3 |
| Placebo | 14 | 29.4 | 10.1 |
| Formulation 088 | 14 | 31.1 | 6.8 |
| Formulation 126 | 14 | 30.3 | 4.1 |
| Formulation 213 | 14 | 30.4 | 5.9 |
| Formulation 625 | 14 | 31.9 | 7.5 |
| Formulation 725 | 14 | 29.6 | 4.4 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 0.8 | 0.3 |
| Formulation 088 | 14 | 1 | .3 |
| Formulation 126 | 14 | 1 | .6 |
| Formulation 213 | 14 | 1 | .4 |
| Formulation 625 | 14 | .9 | .2 |
| Formulation 725 | 14 | .9 | .4 |
| Placebo | 14 | 0.8 | 0.3 |
| Formulation 088 | 14 | 0.9 | 0.2 |
| Formulation 126 | 14 | 1 | 0.6 |
| Formulation 213 | 14 | 1 | 0.4 |
| Formulation 625 | 14 | 0.9 | 0.2 |
| Formulation 725 | 14 | 0.9 | 0.4 |
| Placebo | 14 | 0.8 | 0.3 |
| Formulation 088 | 14 | 1 | 0.3 |
| Formulation 126 | 14 | 1.1 | 0.6 |
| Formulation 213 | 14 | 1.1 | 0.4 |
| Formulation 625 | 14 | 1 | 0.3 |
| Formulation 725 | 14 | 1 | 0.4 |
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 14 | 15.1 | 2.7 |
| Formulation 088 | 14 | 14.6 | 2.8 |
| Formulation 126 | 14 | 15.4 | 4.5 |
| Formulation 213 | 14 | 15.4 | 3.9 |
| Formulation 625 | 14 | 15 | 3.6 |
| Formulation 725 | 14 | 15.9 | 3.3 |
| Placebo | 14 | 14.6 | 2.9 |
| Formulation 088 | 14 | 14.4 | 2.8 |
| Formulation 126 | 14 | 15.1 | 4.6 |
| Formulation 213 | 14 | 15.5 | 4.1 |
| Formulation 625 | 14 | 14.8 | 3.9 |
| Formulation 725 | 14 | 15.3 | 3.3 |
| Placebo | 14 | 13.9 | 2.5 |
| Formulation 088 | 14 | 13.4 | 2.5 |
| Formulation 126 | 14 | 14 | 4.2 |
| Formulation 213 | 14 | 14.3 | 3.5 |
| Formulation 625 | 14 | 13.8 | 3.7 |
| Formulation 725 | 14 | 14.1 | 3.1 |
At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Formulation 725 | 14 | 1751.7 | 271.96 |
| Placebo | 14 | 1755.31 | 289.97 |
| Milestone | All Study Participants |
|---|---|
| STARTED | 26 |
| Formulation 126 Without Meal, | 15 |
| Formulation 213 Without Meal | 14 |
| Formulation 625 Without Meal | 16 |
| Formulation 725 Without Meal | 14 |
| Formulation 088 Without Meal, | 15 |
| Formulation 725 With Meal | 14 |
| Placebo With Meal | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 12 |
Eligibility
primary outcomes
Time frame: Venous blood will be sampled at standardized intervals: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins).
Time frame: venous blood will be sampled at standardized intervals over: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL).
Time frame: venous blood will be sampled at standardized intervals 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L).
Time frame: Randomized visit Including a test meal collected during 235 minutes of TEF
At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT).
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea.
Time frame: Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate
At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo.
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