The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck \& Co., Inc.)under fasting conditions in healthy adult male subjects.
This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fasted conditions. The study was conducted with 26 (25 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Finasteride Tablets 5 mg
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States
Bioequivalence based on Cmax and AUC parameters
Time frame: 2 months
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