Clopidogrel Bioequivalence Study in Healthy Subjects
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention: Clopidogrel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Rainard Fuhr, Dr. med., Principal Investigator, Affiliation: PAREXEL International GmbH, Berlin Glenn Carlson, MD, Study Director, Affiliation: AstraZeneca, Wilmington, US
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]).
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetics of clopidogrel by assessment of area under the curve from time zero extrapolated to infinity (AUC(0-inf))Pharmacokinetics of clopidogrel by assessment of area under the curve from time zero extrapolated to infinity (AUC(0-inf)) Pharmacokinetics of clopidogrel by assessment of observed maximum plasma concentration (Cmax) Pharmacokinetics of clopidogrel by assessment of observed maximum plasma concentration (Cmax)
Secondary outcome: Pharmacokinetics of clopidogrel by assessment of area under the curve from time zero to the time of last quantifiable concentration (AUC(0-last))Pharmacokinetics of clopidogrel by assessment of time to reach the maximum plasma concentration (tmax) Pharmacokinetics of clopidogrel by assessment of terminal half-life (t½λz) Adverse events, blood pressure, pulse, physical examination results, and laboratory assessments (haematology, clinical chemistry, urinalysis ) Pharmacokinetics of clopidogrel by assessment of area under the curve from time zero to the time of last quantifiable concentration (AUC(0-last)) Pharmacokinetics of clopidogrel by assessment of time to reach the maximum plasma concentration (tmax) Pharmacokinetics of clopidogrel by assessment of terminal half-life (t½λz) Adverse events, blood pressure, pulse, physical examination results, and laboratory assessments (haematology, clinical chemistry, urinalysis )
Detailed description:
Study to evaluate the bioequivalence of orally administered European source clopidogrel
tablets and US and Japanese source clopidogrel tablets.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Berlin, Germany
Additional Information
Starting date: August 2014
Last updated: November 4, 2014
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