NCT01380457

Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.

Detailed description

To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.

Conditions

• To Determine Bioequivalence Under Fasting Conditions

Interventions

Type	Name	Description
DRUG	Dronabinol	Capsules, 10 mg, single dose, fasting conditions
DRUG	Marinol	Capsules, 10 mg, single-dose, fasting conditions

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2011-06-27
• Last updated: 2011-06-27

Locations

1 site across 1 country: United States