Journal of Bioequivalence & Bioavailability

Mitchell Kotler

Publications

• Research Article
  Pharmacokinetic and Bioequivalence Study Evaluating a New Paracetamol/Caffeine Formulation in Healthy Human Volunteers
  Author(s): Dongzhou J. Liu, Mitchell Kotler and Scott SharplesDongzhou J. Liu, Mitchell Kotler and Scott Sharples
  
  Purpose: Aim of this study was to evaluate the bioequivalence and clinical pharmacokinetics of newly developed paracetamol 500 mg and caffeine 65 mg combination (PANADOL® EXTRA ADVANCE product), compared with currently marketed conventional paracetamol/caffeine caplet (PANADOL EXTRA® product) in fasted and semi-fed states. Methods: Thirty subjects were enrolled and all completed this 4-way crossover study. Serial blood samples were collected pre-dose until 10-hours post-dose for each period. Plasma samples were assayed for paracetamol and caffeine concentration using HPLC/MS methods. PK parameters were computed using non-compartmental model. Linear mixed-effect model was used to analyze logarithmically transformed AUC0-∞, AUC0-t and Cmax as well as AUC0-30min and AUC0-60min values. Tmax was analyzed by signed rank test on withi.. View More»
  DOI: 10.4172/jbb.1000095

  Abstract PDF