NCT02604992

Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A	Dronabinol oral solution, under fed conditions
DRUG	Treatment B	Dronabinol oral capsule, under fed conditions
DRUG	Treatment C	Dronabinol oral capsule, under fasted conditions

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-11-16
• Last updated: 2016-01-20

Locations

1 site across 1 country: United States