CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Tramadol HCl +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00834288
NCT00834288Phase 1Completed
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A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions

Labopharm Inc.·interventional·Posted Feb 3, 2009·Updated Apr 27, 2012

In Brief

A Phase 1 clinical trial evaluating Tramadol HCl for Healthy Subjects and 2 related conditions. Completed, enrolled 26 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects, Pharmacokinetics, Bioavailability
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartJun 1, 2003
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.4 years ago

Interventions

Tramadol HCldrug

1x200 mg Tramadol HCl OAD tablet daily

Tramadol HCldrug

1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly