NCT01448772

Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions

A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	Dronabinol Capsules, 5 mg	Comparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods
DRUG	Dronabinol Oral Solution	Comparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-10-07
• Last updated: 2012-03-26

Locations

1 site across 1 country: United States