Bioequivalence Study of Finasteride Tablets in Healthy Volunteers
January 2003
in “
The Chinese Journal of Clinical Pharmacology
”
TLDR The two finasteride tablets are bioequivalent.
The study investigated the pharmacokinetics and relative bioavailability of finasteride tablets in 20 healthy male volunteers using a single oral dose of 10 mg in an open randomized cross-over design. The results showed that the test and reference drugs had similar pharmacokinetic parameters, with AUC(o-t) values of 947.41 ± 401.46 and 944.48 ± 349.56 μg·h/L, Cmax values of 106.69 ± 33.45 and 107.49 ± 23.73 μg/L, and TMAX values of 2.40 ± 0.74 and 2.25 ± 0.66 hours, respectively. The relative bioavailability of the test drug was 102.89 ± 38.31%, indicating that the two preparations were bioequivalent.