Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Dronabinol

Criteria

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