BIOEQUIVALENCE EVALUATION OF TIROPRAMIDE HCI 100 MG TABLETS IN HEALTHY MALE KOREAN VOLUNTEERS

  • Lee, Suk (College of Pharmacy and Institute of Bioequivalence and Bridging Study Chonnam National University) ;
  • Cho, Hea-Young (College of Pharmacy and Institute of Bioequivalence and Bridging Study Chonnam National University) ;
  • Kang, Hyun-Ah (College of Pharmacy and Institute of Bioequivalence and Bridging Study Chonnam National University) ;
  • Lee, Yong-Bok (College of Pharmacy and Institute of Bioequivalence and Bridging Study Chonnam National University)
  • Published : 2002.10.01

Abstract

The purposes of this study were to evaluate bioequivalence (BE) using In-transformed pharmacokinetic parameters obtained from two tiropramide HCI products and to develop the analytical methods for the quantitative determination of tiropramide in human serum. In addition. the in vitro dissolution profiles of the two tiropramide HCI products in various dissolution media: pH 1.2, 4.0. 6.8 and water (KP Ⅶ Apparatus II method) were assessed. BE was evaluated in 20 healthy male Korean volunteers in randomized crossover study. (omitted)

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