Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
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Purpose
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 fed conditions following administration of a 3 mg dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Finasteride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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. |
- Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | April 2002 |
| Study Completion Date: | May 2002 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Finasteride
Finasteride tablets 1 mg of Dr. Reddy's
|
Drug: Finasteride
Finasteride tablets 1 mg
Other Name: Propecia
|
|
Active Comparator: Propecia
Propecia 1 mgTablets of Merck & Co.,
|
Drug: Finasteride
Finasteride tablets 1 mg
Other Name: Propecia
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Canada | |
| MDS Pharma Services | |
| Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6 | |
| Principal Investigator: | Gaetano Morelli, MD | MDS Pharma Services |
More Information
No publications provided
| Responsible Party: | Sr. Manager-Research and Development, Dr. Reddy's Laboratories Limited |
| ClinicalTrials.gov Identifier: | NCT01133457 History of Changes |
| Other Study ID Numbers: | 012744 |
| Study First Received: | May 27, 2010 |
| Last Updated: | May 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dr. Reddy's Laboratories Limited:
|
Bioequivalence,Finasteride,Crossover |
Additional relevant MeSH terms:
|
Finasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013