NCT00834808

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tramadol HCl	One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2009-02-03
• Last updated: 2012-04-27
• Results posted: 2009-06-02