- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835796
Finasteride 5 mg Tablets, Non-fasting
September 1, 2009 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77042
- Novum Pharmaceutical Research Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All subjects selected for this study will be male non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.
- Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
Clinical laboratory measurements will include the following:
- Hematology: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count (with differential).
- Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
- Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
- HIV Screen: pre-study
- Hepatitis B, C Screen: pre-study
- Drugs of Abuse Screen: pre-study and at each check-in Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion Criteria:
- Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range on retesting, the subject will not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
- Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
- Subjects who do not tolerate venipuncture will not be allowed to participate.
- Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is require.
- Females will not be eligible to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Finasteride
Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
|
1 x 5 mg, single dose fasting
|
Active Comparator: Proscar®
Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
|
1 x 5 mg, single dose fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 36 hour period
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 36 hour period
|
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 36 hour period
|
Bioequivalence based on AUCinf
|
Blood samples collected over 36 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
July 1, 2002
Study Completion (Actual)
July 1, 2002
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 3, 2009
First Posted (Estimate)
February 4, 2009
Study Record Updates
Last Update Posted (Estimate)
September 11, 2009
Last Update Submitted That Met QC Criteria
September 1, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B026536
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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