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

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

January 31, 2013

Study Completion Date

February 28, 2013

Conditions
Pain
Interventions
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.

Trial Locations (1)

Unknown

Teva Investigational Site 10470, Austin

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01769677 - A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet | Biotech Hunter | Biotech Hunter