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

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.

Timeline

Start

2003-06

Primary completion

2003-08

Completion

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Publications

• Results Karhu D, Fradette C, Potgieter MA, Ferreira MM, Terblanche J. Comparative pharmacokinetics of a once-daily tramadol extended-release tablet and an immediate-release reference product following single-dose and multiple-dose administration. J Clin Pharmacol. 2010 May;50(5):544-53. doi: 10.1177/0091270009347673. Epub 2010 Jan 5.

Drugs

Indications

No indication recorded.