Back to resultsBioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Finasteride
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Bioequivalence,Finasteride,Crossover
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.
Sites / Locations
- MDS Pharma Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Finasteride
Propecia
Arm Description
Finasteride tablets 1 mg of Dr. Reddy's
Propecia 1 mgTablets of Merck & Co.,
Outcomes
Primary Outcome Measures
Bioequivalence based on Cmax and AUC parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT01133457
First Posted
May 27, 2010
Last Updated
May 27, 2010
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01133457
Brief Title
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2002
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
May 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioequivalence,Finasteride,Crossover
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Finasteride
Arm Type
Experimental
Arm Description
Finasteride tablets 1 mg of Dr. Reddy's
Arm Title
Propecia
Arm Type
Active Comparator
Arm Description
Propecia 1 mgTablets of Merck & Co.,
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Propecia
Intervention Description
Finasteride tablets 1 mg
Primary Outcome Measure Information:
Title
Bioequivalence based on Cmax and AUC parameters
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Morelli, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Cohen street, saint-laurent, montreal (quebec)
ZIP/Postal Code
H4R 2N6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
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