Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Finasteride (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Darin B. Brimhall, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
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.
Clinical Details
Official title: A Randomized, Single-dose, Two-treatment, Two-way, Crossover Bioequivalence Study 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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on Cmax and AUC parameters
Detailed description:
This randomized, single-dose, two-treatment, two-way, crossover study was conducted to
compare the relative bioavailability of two formulations of 5 mg finasteride tablets under
fed conditions. The study was conducted with 26 (24 completed) healthy adults. The subjects
received the test product in one study period and the reference product in the other period;
the order of administration was according to the dosing randomization schedule. There was a
7-day interval between treatments.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Males, 18-65 years of age (inclusive).
2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum
Standard Operating Procedures.
3. Good health as determined by lack of clinically significant abnormalities in health
assessments performed at screening.
4. Signed and dated informed consent form, which meets all criteria of current FDA
regulations.
Exclusion Criteria:
1. Female.
2. History of allergy or sensitivity to finasteride, or similar drugs, or history of any
drug hypersensitivity or intolerance which, in the opinion of the Investigator, would
compromise the safety of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system
disorder or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last
year.
5. History of psychiatric disorders occurring within the last two years that required
hospitalization or medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of pharmacologic agents known to significantly induce or inhibit
drug-metabolizing enzymes within 30 days prior to initial dosing.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma
within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
12. Positive test results for drugs of abuse at screening.
Locations and Contacts
Novum Pharmaceutical Research Services, Las Vegas,, Nevada 89121, United States
Additional Information
Starting date: November 2006
Last updated: December 20, 2010
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