Status:
COMPLETED
Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration und...
Eligibility Criteria
Inclusion
- Age: 18 years and older
- Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.
- Weight: At least 60 kg (132 lbs) and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Exclusion
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco products within one year prior to dosing.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
- Medications:
- Use of any medication within the last 14 days prior to the initial dose of study medication, including over-the-counter medications.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Diseases:
- History of any significant chronic disease and/or hepatitis.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, Hepatitis B, or Hepatitis C test result.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to finasteride or other related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00650377
Start Date
October 1 2004
End Date
October 1 2004
Last Update
April 23 2024
Active Locations (1)
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1
Kendle International Inc.
Morgantown, West Virginia, United States, 26505