Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg

Inclusion criteria

• 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 criteria

• 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.