Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg

NCT00648791 | Completed Phase 1

• 1 other identifier: FINA-0460
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets to Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

Finasteride Tablets 5 mg

Drug: Finasteride Tablets 5 mg

2

ACTIVE COMPARATOR

Proscar Tablets 5 mg

Drug: Proscar Tablets 5 mg

Interventions

Finasteride Tablets 5 mg DRUG

5mg, single dose fasting

1

Proscar Tablets 5 mg DRUG

5mg, single dose fasting

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Finasteride

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Dorian Williams, M.D.

  Kendle International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: September 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)