P-215 Study on Bioequivalence of Finasteride Tablet in Healthy Volunteers
September 2005
in “
日本医療薬学会年会講演要旨集
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research Bioequivalence of a Single 10-mg Dose of Finasteride 5-mg Oral Disintegrating Tablets and Standard Tablets in Healthy Adult Male Han Chinese Volunteers: A Randomized Sequence, Open-Label, Two-Way Crossover Study
Finasteride 5-mg oral disintegrating tablets and standard tablets are bioequivalent in healthy adult male Han Chinese volunteers.
research Bioequivalence of Finasteride Tablets in Healthy Volunteers
The study aimed to evaluate the bioequivalence of finasteride tablets by analyzing their pharmacokinetics and relative bioavailability in 21 healthy male volunteers using a two-way crossover trial design. Plasma concentrations were measured after a single oral dose of 20 mg finasteride. The results showed that the pharmacokinetic parameters, including AUC0-tn, AUC0-∞, tmax, ρmax, and t1/2, were similar between the test and reference tablets. The study concluded that the two types of finasteride tablets were bioequivalent.