At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 144 enrolled

Drug / intervention

Clopidogreldrug

Likely dose

Clopidogrel 75 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.

Search/NCT02185534

NCT02185534Phase 1Completed

Compare CT.gov

An Open-label, Randomised, Three-way Crossover Study in Healthy Subjects to Assess the Bioequivalence of European Source Generic Clopidogrel Tablets and US and Japanese Source Branded Clopidogrel (Plavix®) Tablets.

AstraZeneca·interventional·Posted Jul 9, 2014·Updated Jun 22, 2016

In Brief

A Phase 1 clinical trial evaluating Clopidogrel for Bioequivalence, AUC, Cmax, Pharmacokinetics. Completed, enrolled 144 participants across 1 site.

Detailed Summary

This study will be an open-label, randomised, three-way crossover study in healthy male and female subjects, performed at a single centre. The objective of the study is to assess the bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister from KRKA) and two reference formulations (Clopidogrel 75 mg tablet \[Plavix, sourced in US and Japan\]).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBioequivalence, AUC, Cmax, Pharmacokinetics

CountriesGermany

Collaborators--

Timeline

Phase 1CompletedFinished

201520162017201820192020202120222023202420252026

First PostedJul 2014

Enrollment StartAug 2014

Primary CompletionOct 2014

TodayJul 2026

First PostedJul 9, 2014

Enrollment StartAug 1, 2014

Primary CompletionOct 1, 2014

TodayJul 2, 2026

Enrollment to primary: 2 monthsPosted 12.0 years ago

Interventions

Clopidogreldrug

European clopidogrel tablets, 75 mg (test) versus Japanese clopidogrel tablets, 75 mg (reference); European clopidogrel tablets, 75 mg (test) versus US clopidogrel tablets, 75 mg (reference)