OBJECTIVE To evaluate the bioequivalence of domestic finasteride tablet and imported tablet. METHODS A single oral dose of 10 mg domestic tablet or imported tablet was given to 20 healthy volunteers in a randomized crossover study. The concentrations of finasteride were determined by HPLC method. RESULTS The main pharmacokinetic parameters of the two products were as follows:AUQ0-24(840.63±140.84) and (847.51±166.96) ng-h-mL-1, cmax(117.17±19.74) and (117.43±18.06) ng·mL-1, tmax(1.88±0.48) and (1.95±0.43)h,respectively. The relative bioavailability of domestic tablet to imported tablet was (100.73土15.27)%. There were no significant differences on the pharmacokinetic parameters between the two preparations(P>0.05). CONCLUSION The results demonstrated that the two preparations were bioequivalent.
Key words
finasteride /
HPLC /
pharmacokinetics /
bioequivalence
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References
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Footnotes
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