PharmPK Discussion - BE with Levodopa

• On 26 Aug 2004 at 17:28:19, "Silvia Giarcovich" (research.aaa.diffucap.com) sent the message
  

  
  Dear all:
  We have to perform a BE study with Levodopa and the bibliography
  indicates emesis as a probable adverse event particularly if one
  administrates the doses we will have to in the BE study.
  Bibliography suggests to administrate simultaneously either domperidone
  or an extra dose of carbidopa/benserazide. So, the alternatives are:
  *    Levopoda alone:                     Risk of missing voluntaries
  samples.
  *    Levodopa + Carbidopa/Benserazide:   Long pretreatment (compliance?)
  *    Levodopa + Domperidone:             Domperidone affects absorption
  (will affect in the same way both Test and Ref)
  We will be grateful if the group shares any experience in case someone
  has already worked with this drug substance.
  Thanks to all, Silvia
  

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• On 31 Aug 2004 at 18:28:07, "Kanthikiran Varanasi" (kanthikiranv.at.glenmarkpharma.com) sent the message
  

  
  Dear Silvia,
  We have worked earlier with SINEMET CR which is a combination of
  LEVODOPA 50 mg + CARBIDOPA 200 mg and found no emesis at that time. So I
  don't think there may a risk of missing volunteers even at n=12 as per
  our data.
  Regards,
  KANTHI KIRAN V.S. VARANASI, M.Pharm, MBA
  Drug Metabolism and Pharmacokinetics Department,
  Glenmark Pharmaceuticals LTD.
  INDIA.
  

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• On 1 Sep 2004 at 18:26:27, "Silvia Giarcovich" (research.at.diffucap.com) sent the message
  

  
  Dear KANTHI KIRAN V.S. VARANASI:
  Thanks for your response. Actually, we have one CR formulation and we
  appreciate your experience.
  However, other two formulations are immediate release (250 Levodopa/25
  Carbidopa and 100 Levodopa/25 Carbidopa) and emesis is reported at these
  concentrations.
  Kind regards, Silvia
  

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