- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185534
Clopidogrel Bioequivalence Study in Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture.
Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating and
• if of non child-bearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• if of child-bearing potential and are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 3 months after the last dose of IMP.
- Have a body mass index between 18,5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Be able to understand, read and speak the German language.
Exclusion criteria
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.
- Current smokers or those who have smoked or used nicotine products within the previous 3 months.
- History of haemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
- A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the Investigator.
- Use of aspirin, ibuprofen, NSAIDS, or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: European clopidogrel tablets, 75 mg
Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet (Zyllt, KRKA - test)
|
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)
Other Names:
|
Active Comparator: Japanese clopidogrel tablets, 75 mg
Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi-Aventis, reference)
|
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)
Other Names:
|
Active Comparator: US clopidogrel tablets, 75 mg
Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Time Frame: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.
|
0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time Frame: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.
|
0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))
Time Frame: 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.
|
0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rainard Fuhr, Dr. med., PAREXEL International GmbH, Berlin
- Study Director: Glenn Carlson, MD, Astrazeneca, Wilmington, US
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5130C00131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bioequivalence, AUC, Cmax, Pharmacokinetics
-
AstraZenecaCompletedBioequivalence, AUC, Cmax, PharmacokineticsUnited States
-
GeropharmCompletedBioequivalence, AUC, Cmax, PharmacokineticsRussian Federation
-
AstraZenecaCompletedPharmacokinetics | Relative Bioavailability | AUC | CmaxUnited States
-
AstraZenecaCompletedAsthma, | Pharmacokinetics, | Cmax, | Tmax, | λz, | AUC, | Ketoconazole, | MetaboliteUnited Kingdom
-
AstraZenecaCompletedSafety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and TmaxUnited Kingdom
-
AstraZenecaCompletedBioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and MetforminUnited States
-
GeropharmCompletedPharmacokinetics | BioequivalenceRussian Federation
-
Zogenix, Inc.CompletedPharmacokinetics | BioequivalenceUnited States
-
AstraZenecaCompletedPharmacokinetics | Bioequivalence | Healthy Japanese SubjectsUnited Kingdom
-
GeropharmRecruitingPharmacokinetics | Pharmacodynamics | BioequivalenceRussian Federation
Clinical Trials on Clopidogrel
-
Korea University Anam HospitalCompleted
-
Chinese PLA General HospitalUnknownCLOPIDOGREL, POOR METABOLISM of (Disorder)China
-
Ospedale San DonatoCompletedAcute Myocardial InfarctionItaly
-
University of PecsTerminatedStable Angina Pectoris | Ad Hoc Percutaneous Coronary InterventionHungary
-
Hospital Central San Luis Potosi, MexicoUnknownAcute Coronary Syndrome
-
University of North Carolina, Chapel HillCompleted
-
Lady Reading Hospital, PakistanPakistan Chest Society, PakistanRecruitingCOPD | COPD Exacerbation AcutePakistan
-
Deutsches Herzzentrum MuenchenTerminatedCoronary Artery DiseaseGermany
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaCompleted