Pharmacokinetics and Bioequivalence of Finasteride Tablets in Healthy Subjects
January 2003
in “
Zhongguo yaoke daxue xuebao
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research Bioequivalence Study of Finasteride
Finasteride's two formulations absorb similarly, showing bioequivalence.
research Determination of Finasteride by HPLC-MS and Study Its Pharmacokinetics
research Determination of Finasteride in Human Plasma and Its Pharmacokinetics and Relative Bioavailability by HPLC-Electrospray Mass Spectrometry
research Determination of Finasteride in Human Plasma by HPLC-MS and Study on the Bioequivalence of Domestic and Import Finasteride Tablets
The study established an HPLC-MS method to determine finasteride levels in plasma and assessed the bioequivalence of domestic and imported finasteride tablets. In a randomized crossover study with 20 healthy volunteers, each received a single 5 mg dose of both tablet types. The results showed that the calibration curve for finasteride was linear, with high recovery rates from plasma and low variability in measurements. The pharmacokinetic parameters, including AUC and C_max, were similar for both tablet types, and the relative bioavailability of domestic to imported tablets was 103.20%±15.08%. The study concluded that there were no significant differences between the two preparations, confirming their bioequivalence. The HPLC-MS method was found to be accurate and sensitive for finasteride determination.