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Clopidogrel Bioequivalence Study in Healthy Subjects

NCT02185534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-06-22

Study results available
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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 \[Plavix, sourced in US and Japan\]).

Conditions

  • Bioequivalence, AUC, Cmax, Pharmacokinetics

Interventions

DRUG

Clopidogrel

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)

Sponsors & Collaborators

Principal Investigators

  • Rainard Fuhr, Dr. med. · PAREXEL International GmbH, Berlin

  • Glenn Carlson, MD · AstraZeneca, Wilmington, US

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02185534 on ClinicalTrials.gov