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Pharmacokinetics, bioequivalence, and safety studies of gefitinib tablet formulations: a randomized, open-label, two-period, two-sequence crossover study in Chinese healthy volunteers
  • +4
  • Ping Du,
  • Zhixia Zhao,
  • Weiyue Yu,
  • Rui Zhao,
  • Hongchuan Liu,
  • Pengfei Li,
  • Lihong Liu
Ping Du
Beijing Chao-Yang Hospital Capital Medical University

Corresponding Author:pingdu2012@163.com

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Zhixia Zhao
Beijing Chaoyang Hospital
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Weiyue Yu
Beijing Chao-Yang Hospital Capital Medical University
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Rui Zhao
Beijing Chao-Yang Hospital Capital Medical University
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Hongchuan Liu
Beijing Chao-Yang Hospital Capital Medical University
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Pengfei Li
Beijing Chao-Yang Hospital, Capital Medical University
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Lihong Liu
Beijing Chao-Yang Hospital Capital Medical University
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Abstract

Aims: A randomized, open-label, two-period, two-sequence crossover study was carried out for evaluating the bioequivalence of test (T) and reference (R) formulation of gefitinib in healthy Chinese volunteers. Methods: A total of eighty subjects were enrolled and randomized into two sequence groups. All subjects were orally administered of T or R formulation at dose of 250 mg. The plasma samples were obtained at before and after administration until post-dose 168 hour, and the drug concentrations were analyzed using validated high-performance liquid chromatography-tandem mass spectrometry method. Results: The 90% confidence interval of the geometric mean ratios were all within the range of 0.80-1.25 under fasting and fed conditions. As for the safety of both formulations, no serious or unexpected adverse events occurred during the study. Conclusions: Overall, the T formulation was bioequivalent with R formulation under fasting and fed conditions.