NCT00834288

A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.

Conditions

• Healthy Subjects
• Pharmacokinetics
• Bioavailability

Interventions

Type	Name	Description
DRUG	Tramadol HCl	1x200 mg Tramadol HCl OAD tablet daily
DRUG	Tramadol HCl	1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-08-01
• First posted: 2009-02-03
• Last updated: 2012-04-27
• Results posted: 2009-10-19