Abstract
OBJECTIVE To study the phamacokinetics and relative bioavailability, and to evaluate the bioequivalence of finestaride tablets. METHODS 21 male subjects were involved in a two-way crossover trial design, plasma concentrations were determined by HPLC method following a single oral dose of 20 mg finasteride preparation.RESULTS The pharmacokinetic parameters of the test tablets and the reference tablets in plasma were as follows, AUC0~tn (1 413.9±614.9) and (1 450.4±684.5)μg·h·L-1 ,AUC0~∞(1 460.3 ±641.7) and (1 499.9±711.6)μg·h·L-1,tmax(2.86±0.3) and (2.90±0.3)h,ρmax(216.3±83.4 and (209±83.9)μg·L-1,t1/2(2.34±0.5) and (2.29±0.4)h. CONCLUSION The two kinds of finasteride tablet are of bioequivalence.
Key words
finasteride /
HPLC /
bioavailability /
bioequivalence
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XU Xio-hong;LI Tong-ling;YN Lin;ZHNG Rong-qin;FENG Ling;ZHENG Peng-cheng.
Bioequivalence of finasteride tablets in healthy volunteers [J]. Chinese Pharmaceutical Journal, 2005, 39(22): 1727-1729
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Footnotes
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