Bioequivalence Study of Finasteride Tablets in Healthy Volunteers

OBJEIVE To study the pharmacokinetics and relative bioavailability of finasteride tablets in 20 healthy volunteers.METHODS: A single oral dose 10mg of finasteride test or reference drugs were given to 20 healthy male volunteers according to an open randomizedin cross-over design. Finasteride concentrations in serum were determined by HPLC . The pharmacokinetics parameters and relative bioavailability were calculated by NDST-21 program .RESULT AUC(o-t) of reference and test drug were 947.41 ± 401.46 and 944.48 ± 349.56 ± g ·h μL-1, Cmax were 106.69 ±33.45 and107.49 ±23.73 μ g ·L-1, TMAX were 2.40 ± 0.74 and2.25 ±0.66h, respeively. The relative bioavailability of the test drug was(102.89 ± 38.31)%, CONCLUSION The result of statistical analysis showed that two preparations were bioequivallent.