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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01133457
• Date of registration: 27/05/2010
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
• Scientific title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.
• Date of first enrolment: April 2002
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01133457
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Gaetano Morelli, MD
• Affiliation: MDS Pharma Services

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Finasteride

Primary Outcome(s)

Bioequivalence based on Cmax and AUC parameters [Time Frame: 3 months]

Secondary ID(s)

012744

Source(s) of Monetary Support

Please refer to primary and secondary sponsors