PharmPK Discussion - Clopidogrel - highly variable drug

• On 30 Jul 2012 at 19:22:37, Peh Kok-Khiang (kkpehken.at.gmail.com) sent the message
  

  
  Dear All,
  
  Has clopidogrel been reported to be a highly variable drug ?
  
  We found some articles using very high number of subjects in bioequivalence study. One study used up to 96 subjects.
  
  We tried to estimate the number of subjects based upon the published results and found out that the power was < 80% even using 96 subjects in BE study.
  
  Your advice is highly appreciated.
  
  Thank you.
  
  Regards,
  Ken
  
  

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• On 30 Jul 2012 at 22:29:21, DRGUNA SAKARAN (drgunasakaran.-at-.gmail.com) sent the message
  

  
  Dear Dr Ken,
  Clopidogrel is a highly variable drug. It is highly recommended to go for
  Replicate study design for Clopidogrel BE study.
  
  One study submitted for EMA was conducted as an open label, randomized, two
  treatment, two sequence, four way, replicate cross over study with 74 subjects.
  
  Reference:
  Public Assessment Report, Decentralized procedure, Clopidogrel Alet 75 mg Film
  coated tablets (UK/H/3581 & 3583), Clealet 75 mg Film coated tablets
  (UK/H/3582), Plegrin 75 mg Film coated tablets (UK/H/3584), UK/H/3581-4/001/DC,
  UK License nos. PL 32313/0028-31
  http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084665.pdf
  
  A single-dose, pharmacokinetic study of Plavix 75 mg film-coated tablets under
  fasting conditions was conducted with the objective to estimate the
  intra-subject variability of the pharmacokinetic parameters AUC0-t , AUC0-inf
  and Cmax of Plavix 75 mg Tablets (Sanofi Pharma Bristol-Myers Squibb SNC,
  France) after a single-dose in healthy subjects under fasting conditions. It was
  an open-label, single-dose, two-period, single-treatment cross-over study,
  performed on 18 healthy males and females volunteers using a 75 mg single dose
  under fasting conditions (Study code: X-1706).
  The literature reported intrasubject CV% for AUC0-t, AUC0-inf and Cmax were 40%,
  41% and 47%.
  
  Reference:
  Assessment Report of Clopidogrel Teva, Procedure No. EMEA/H/C/001053
  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001053/WC500031168.pdf
  
  Regards,
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affairs,
  Azidus Clinical Research Organization, India
  www.azidus.com
  

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• On 31 Jul 2012 at 21:39:19, Laszlo Endrenyi (l.endrenyi.at.utoronto.ca) sent the message
  

  
  The following message was posted to: PharmPK
  
  The recent paper entitled "Sample sizes for designing bioequivalence studies for
  highly variable drugs" (J. Pharm. Pharmaceut. Sci., 2011; 15(1):73-84) could be
  of interest.
  
  Laszlo Endrenyi
  

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