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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

Page last updated: August 23, 2015

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