Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.
To Determine Bioequivalence Under Fasting Conditions
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions|
- Bioequivalence [ Designated as safety issue: No ]To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.
|Study Start Date:||January 2006|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions
Capsules, 10 mg, single dose, fasting conditions
Other Name: Marinol
Active Comparator: B
Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.
Capsules, 10 mg, single-dose, fasting conditions
Other Name: Dronabinol
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.
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Dilip K Guha-Ray, M.D.||BASi Baltimore Clinical Research Unit|