The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®) 1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Finasteride tablets 1 mg
MDS Pharma Services
Cohen Street, Saint-laurent, Montreal (quebec), Canada
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
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