At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Tramadol Contramid OAD +1 moredrug
Likely dose
Tramadol Contramid OAD 200 mgfrom 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.
Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg
In Brief
A Phase 1 clinical trial evaluating Tramadol Contramid OAD and Zytram for Pain. Completed, enrolled 26 participants.
Detailed Summary
The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
Primary CompletionMar 2004
First PostedJun 2009
TodayJul 2026
First PostedJun 2, 2009
Enrollment StartFeb 1, 2004
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Tramadol Contramid OADdrug
1 Tramadol Contramid OAD 200 mg tablet as a single dose
Zytramdrug
1 Zytram 200 mg tablet as a single dose