Pharmacokinetics And Bioequivalence Of Finasteride Tablets In Healthy Subjects
January 2003
in “
Zhongguo yaoke daxue xuebao
”
TLDR The two finasteride tablet formulations are bioequivalent.
The study aimed to develop an HPLC-ESI-MS assay for determining finasteride in human plasma and to investigate the pharmacokinetics and bioequivalence of finasteride tablets. A randomized crossover design was conducted with 20 healthy volunteers, each receiving a single 5 mg dose of both test and reference tablets. The main pharmacokinetic parameters for the reference tablet were t1/2 of 4.6±1.2 h, tmax of 3.1±0.9 h, and cmax of 59.4±17.9 ng/ml, while the test tablet showed t1/2 of 4.4±1.1 h, tmax of 2.8±1.2 h, and cmax of 63.6±22.9 ng/ml. The relative bioavailability of the reference tablet was 96.9±14.6%. The study concluded that the assay was sensitive, accurate, and convenient, and the two formulations were bioequivalent.