A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers

Summary

The purposes of this study were: * To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid. * To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.

Timeline

Start

2002-11

Primary completion

2002-12

Completion

2002-12

Publications

• Results Karhu D, El-Jammal A, Dupain T, Gaulin D, Bouchard S. Pharmacokinetics and dose proportionality of three Tramadol Contramid OAD tablet strengths. Biopharm Drug Dispos. 2007 Sep;28(6):323-30. doi: 10.1002/bdd.561.

Drugs

Indications

No indication recorded.