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

Phase 1 Completed 26 enrolled Labopharm Inc.

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2004-02
Primary completion: 2004-03
Completion: 2004-03

Publications

Results Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tramadol	Other / unclassified	200 mg	Oral

Indications

No indication recorded.