Journal of Bioequivalence & Bioavailability

Elie Daccache

Publications

• Research Article
  Bioequivalence of Losartan/Amlodipine Fixed Dose Combination Tablets (Losanet AM) Compared with Concomitant Administration of Single Components of Losartan and Amlodipine Tablets in Healthy Human Volunteers
  
  Author(s): Rana Bustami, Sewar Khasawneh, Wafaa’ Absi, Hamzeh Feddah, Mohamad Mroueh, Elie Daccache, Jean-Charles Sarraf and Soula KyriacosRana Bustami, Sewar Khasawneh, Wafaa’ Absi, Hamzeh Feddah, Mohamad Mroueh, Elie Daccache, Jean-Charles Sarraf and Soula Kyriacos
  
  A fixed dose combination of losartan, an angiotensin receptor blocker and amlodipine, a calcium channel blocker, can potentially provide complementary mechanism of action to improve blood pressure control and clinical outcomes. The current study was conducted to compare the pharmacokinetics of a new combination product of losartan potassium and amlodipine besylate with separate co-administration of losartan potassium and amlodipine besylate tablets in 40 healthy human volunteers after a single oral dose in a randomized three-period crossover study. The study protocol was prepared in accordance to the requirements set in the EMA guidance for conducting bioequivalence studies. Reference (Cozaar 100 mg, Merck Sharp & Dohme Ltd, UK and Norvasc 10 mg, Pfizer, Canada) and test (Losanet AM, Pharmaline, Lebanon) drugs were administered to fasted volunteers and blood samples were collected.. View More»
  DOI: 10.4172/jbb.1000243

  Abstract