Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition

Launched by DR. REDDY'S LABORATORIES LIMITED · May 27, 2010

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• Exclusion Criteria:
• History or presence of significant:
• • • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
• In addition, history or presence of:
• • alcoholism or drug abuse within the past year;
• • hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor.
• • Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
• Subjects who, through completion of the study, would have donated in excess of:
• • 500 mL of blood in 14 days, or
• • 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
• • 1000 mL of blood in 90 days,
• • 1250 mL of blood in 120 days,
• • 1500 mL of blood in 180 days,
• • 2000 mL of blood in 270 days,
• • 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.