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Trial record 60 of 6064 for:    zero

Clopidogrel Bioequivalence Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02185534
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : November 30, 2015
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 4, 2014
First Posted Date  ICMJE July 9, 2014
Results First Submitted Date  ICMJE September 18, 2015
Results First Posted Date  ICMJE November 30, 2015
Last Update Posted Date June 22, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • 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 the US.
  • 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.
  • 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.
  • 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 Japan.
Change History Complete list of historical versions of study NCT02185534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • 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.
  • Pharmacokinetics of clopidogrel by assessment of time to reach the maximum plasma concentration (tmax) [ 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 time to reach the maximum plasma concentration, taken directly from the individual concentration-time curve, tmax, of clopidogrel sourced in Europe and the US.
  • Pharmacokinetics of clopidogrel by assessment of terminal half-life (t½λz) [ 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 terminal half-life, estimated as (ln2)/λz, where λz refers to the terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve, t½λz, of clopidogrel sourced in Europe and the US.
  • Adverse events, blood pressure, pulse, physical examination results, and laboratory assessments (haematology, clinical chemistry, urinalysis ) [ Time Frame: From screening to until follow-up. ]
    To compare the safety and tolerability of European source generic clopidogrel tablets and US source branded clopidogrel (Plavix®) tablets
  • 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 Japan.
  • Pharmacokinetics of clopidogrel by assessment of time to reach the maximum plasma concentration (tmax) [ 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 time to reach the maximum plasma concentration, taken directly from the individual concentration-time curve, tmax, of clopidogrel sourced in Europe and Japan.
  • Pharmacokinetics of clopidogrel by assessment of terminal half-life (t½λz) [ 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 terminal half-life, estimated as (ln2)/λz, where λz refers to the terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve, t½λz, of clopidogrel sourced in Europe and Japan.
  • Adverse events, blood pressure, pulse, physical examination results, and laboratory assessments (haematology, clinical chemistry, urinalysis ) [ Time Frame: From screening to until follow-up. ]
    To compare the safety and tolerability of European source generic clopidogrel tablets and Japanese source branded clopidogrel (Plavix®) tablets
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel Bioequivalence Study in Healthy Subjects
Official Title  ICMJE 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.
Brief 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]).
Detailed Description Study to evaluate the bioequivalence of orally administered European source clopidogrel tablets and US and Japanese source clopidogrel tablets.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention  ICMJE 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 Names:
  • Zyllt
  • Plavix
Study Arms  ICMJE
  • Experimental: European clopidogrel tablets, 75 mg
    Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet (Zyllt, KRKA - test)
    Intervention: Drug: Clopidogrel
  • 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)
    Intervention: Drug: Clopidogrel
  • Active Comparator: US clopidogrel tablets, 75 mg
    Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
    Intervention: Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2014)
144
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2014)
84
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02185534
Other Study ID Numbers  ICMJE D5130C00131
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainard Fuhr, Dr. med. PAREXEL International GmbH, Berlin
Study Director: Glenn Carlson, MD AstraZeneca, Wilmington, US
PRS Account AstraZeneca
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP