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Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

NCT01264302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-12-21

No results posted yet for this study

Summary

The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck \& Co., Inc.)under fed conditions in healthy adult male subjects.

Conditions

  • Healthy

Interventions

DRUG

Finasteride

Finasteride Tablets 5 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Darin B. Brimhall · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01264302 on ClinicalTrials.gov