Clopidogrel Bioequivalence Study in Healthy Subjects
Condition: Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention: Clopidogrel
Intervention description: 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)
Intervention MeSH terms: Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clopidogrel, Zyllt, Plavix, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence

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]).
    

Eligibility 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.