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History of Changes for Study: NCT01133444
Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
Latest version (submitted July 9, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 27, 2010 None (earliest Version on record)
2 July 9, 2010 Study Status
Comparison Format:

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Study NCT01133444
Submitted Date:  July 9, 2010 (v2)

Open or close this module Study Identification
Unique Protocol ID: 012742
Brief Title: Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting 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 Under Fasting Condition.
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2010
Overall Status: Completed
Study Start: April 2002
Primary Completion: April 2002 [Actual]
Study Completion: May 2002 [Actual]
First Submitted: May 27, 2010
First Submitted that
Met QC Criteria:
May 27, 2010
First Posted: May 28, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 9, 2010
Last Update Posted: July 12, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Dr. Reddy's Laboratories Limited
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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 fasting 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.
Open or close this module Conditions
Conditions: Healthy
Keywords: Bioequivalence,Finasteride,Crossover
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 24 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Finasteride
Finasteride tablets 1 mg of Dr. Reddy's
Drug: Finasteride
Finasteride tablets 1 mg
Other Names:
  • Propecia
Active Comparator: Propecia
Propecia 1 mgTablets of Merck & Co.,
Drug: Finasteride
Finasteride tablets 1 mg
Other Names:
  • Propecia
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Bioequivalence based on Cmax and AUC parameters

[Time Frame: 3 months]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Study Officials: Gaetano Morelli, MD
Principal Investigator
MDS Pharma Services
Locations: Canada
MDS Pharma Services
Cohen street, saint-laurent, montreal (quebec), Canada, H4R 2N6
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services