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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2004, Vol. 9 ›› Issue (12): 1411-1414.

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Bioequivalance of single oral administration of finasteride tablet and capsule in healthy volunteers

ZHAO Ya-Nan, QIU Fu-Rong, WANG Wei-Jia, SUN Hua, DAI Min, YANG Qing-Qing, MAO Guo-Guang   

  1. National Drug Clinical Research Base, Yijishan Hospital, Wannan Medical College, Wuhu 241001, Anhui, China
  • Received:2004-07-28 Revised:2004-11-10 Online:2004-12-26 Published:2020-11-19

Abstract: AIM: To study the bioequivalance of finasteride tablet and capsule in 24 healthy volunteers. METHODS: A reversed-phase high performance liquid chromatography (RP-HPLC) method was established for the determination of the finasteride concentrations in human plasma after a single oral dose administration of 15 mg finasteride tablet and capsule and control finasteride tablet (control group) to 24 healthy volunteers in an open randomized crossover design.RESULTS: The main pharmacokinetic parameters of finasteride tablet group, capsule group and finasteride tablet group were as follows:T1 2 ke were 4.38±0.90, 4.29±0.78 and 4.32±0.86 h;Tmax were 3.04±0.88, 2.98±0.89 and 2.59±0.86 h;Cmax were 117.57±19.15, 118.59±20.23 and 124.53±19.77 μg·L-1;AUC0-18 were 897.57±185.03, 871.57±139.25 and 837.59±149.05 μg·h·L-1;AUC0-∞ were 970.04±211.83, 931.51±151.07 and 896.41±164.92 μg·h·L-1, respectively. CONCLUSION: The finasteride tablet and capsule and the control finasteride tablet are bioequivalent.

Key words: finasteride, bioavailability, pharmacokinetics, HPLC

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