NCT00911742

Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg

Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Tramadol Contramid OAD	1 Tramadol Contramid OAD 200 mg tablet as a single dose
DRUG	Zytram	1 Zytram 200 mg tablet as a single dose

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2009-06-02
• Last updated: 2012-04-27
• Results posted: 2009-06-02