Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | December 2015 |
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
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.
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.
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:
1. the safety or well-being of the participant or study staff
2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding)
3. the analysis of results
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