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The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (A,B,C) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C. |
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| Group 2 (B,C,A) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A. |
|
| Group 3 (C,A,B) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B. |
|
| Group 4 (C,B,A) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A. |
|
| Group 5 (A,C,B) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Dronabinol oral solution, under fed conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 to the last measured concentration | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Area under the curve extrapolated to infinity | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Maximum plasma concentration | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Time to reach maximum plasma concentration | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Elimination rate constant | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| The time prior to the first measurable (non-zero) concentration | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Elimination half-life | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. | |
| Apparent oral clearance |
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Inclusion Criteria:
Exclusion Criteria:
History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Neha Parikh | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Group 6 (B,A,C) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C. |
|
| Treatment B | Drug | Dronabinol oral capsule, under fed conditions |
|
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| Treatment C | Drug | Dronabinol oral capsule, under fasted conditions |
|
|
| 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. |
| Volume of distribution | 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose. |