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

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Pain
Interventions
DRUG

a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-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 10471, Austin

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01758978 - A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet | Biotech Hunter | Biotech Hunter