Bioequivalence of Finasteride Tablet in Healthy Volunteers by LC-MS/MS
January 2010
in “
Chinese Journal of Hospital Pharmacy
”
TLDR The two finasteride tablets are bioequivalent.
The study assessed the pharmacokinetics and bioequivalence of finasteride tablets in 24 healthy male volunteers using an LC-MS/MS assay. Each participant received a single oral dose of 1 mg of both test and reference tablets in an open randomized crossover design. The pharmacokinetic parameters, including AUC0-36, AUC0-∞, Tmax, Cmax, and t1/2, showed no statistically significant differences between the test and reference preparations. The relative bioavailability was 106.0±20.9%. The study concluded that the two finasteride tablet preparations were bioequivalent.