NCT01769677

A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 45-mg and One 90-mg Hydrocodone Bitartrate Extended-Release Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).	Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2013-01-17
• Last updated: 2013-03-20

Locations

1 site across 1 country: United States