Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
NCT ID: NCT01133457
Last Updated: 2010-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2002-04-30
2002-05-31
Brief Summary
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1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Finasteride
Finasteride tablets 1 mg of Dr. Reddy's
Finasteride
Finasteride tablets 1 mg
Propecia
Propecia 1 mgTablets of Merck \& Co.,
Finasteride
Finasteride tablets 1 mg
Interventions
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Finasteride
Finasteride tablets 1 mg
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
• 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Dr. Reddy's Laboratories Limited
Principal Investigators
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Gaetano Morelli, MD
Role: PRINCIPAL_INVESTIGATOR
MDS Pharma Services
Locations
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MDS Pharma Services
Cohen Street, Saint-laurent, Montreal (quebec), , Canada
Countries
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Other Identifiers
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012744
Identifier Type: -
Identifier Source: org_study_id