Clopidogrel bioequivalence study in healthy subjects

Study identifier:D5130C00131

ClinicalTrials.gov identifier:NCT02185534

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Bioequivalence, AUC, Cmax, Pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Clopidogrel

Sex

All

Actual Enrollment

144

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Aug 2014

Primary Completion Date: 01 Oct 2014

Study Completion Date: 01 Oct 2014

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 May 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

Location

Research Site

Berlin, Germany

Arms	Assigned Interventions
Experimental: European clopidogrel tablets, 75 mg Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet (Zyllt, KRKA - test)	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) Other Name: Zyllt Other Name: Plavix
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)	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) Other Name: Zyllt Other Name: Plavix
Active Comparator: US clopidogrel tablets, 75 mg Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)	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) Other Name: Zyllt Other Name: Plavix