Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets protocol-specified criteria for qualification Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator 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: the safety or well-being of the participant or study staff the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) the analysis of results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (A,B,C)<br>With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|
| Experimental: Group 2 (B,C,A)<br>With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|
| Experimental: Group 3 (C,A,B)<br>With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|
| Experimental: Group 4 (C,B,A)<br>With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|
| Experimental: Group 5 (A,C,B)<br>With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|
| Experimental: Group 6 (B,A,C)<br>With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C. | Drug: Treatment A<br>* Dronabinol oral solution, under fed conditions<br>Drug: Treatment B<br>* Dronabinol oral capsule, under fed conditions<br>* Other names: Marinol;Drug: Treatment C<br>* Dronabinol oral capsule, under fasted conditions<br>* Other names: Marinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparative Bioavailability