Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02604992

Run by

INSYS Therapeutics Inc

People needed

54

Starts

2015-11-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Worldwide Clinical Trials Early Phase Services, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.