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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2002, Vol. 7 ›› Issue (5): 437-439.

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Evaluation of bioequivalence of domestic glimepiride tablet in Chinese healthy male volunteers

WANG Shao-Hua, CHEN An-Jin, YU Bao-Dong, CHU Xiao, SHI Jie, ZHAO Mei-Ling   

  1. Nation Base of Drug Clinical Trial of Qingdao Municipal Hospital, Qingdao 266011
  • Received:2002-03-30 Revised:2002-07-24 Published:2020-11-26

Abstract: AIM: To compare the bioequivalence of glimepiride tables and capsules with a single dose. METHODS: Twenty Chinese healthy male volunteers were enrolled in a randomized crossover study with a single oral dose 3 mg of two formulations respectively.The blood drug concentration in serum was measured by HPLC, and the pharmacokinetic parameters were calculated by 3p97 software and compared by two one-side ttest. RESULTS: The parameters of the tables and the capsules were (1.23 ± 0.19) and (1.31 ± 0.22) mg·h·L-1at AUC(0 -t), (1.32 ±0.20) and (1.45 ± 0.24) mg·h·L-1 at AUC(0-inf), (0.30 ±0.05) and (0.30 ±0.06) mg·L-1 at Cmax, (6.6 ±2.5) and (9.3 ±7.9) h the peak time (Tpeak), respectively.There were no significant differences between the two formulations. F was 96.4 ±21.1 calculated by AUC(0 -t) and 96.4 ± 21.1 by AUC(0-inf). CONCLUSION: Glimepiride tables and capsules are of bioequivalence.

Key words: glimepiride, HPLC, bioequivalence

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