Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: Terbinafine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Steven Herrmann, MD, Principal Investigator, Affiliation: Gateway Medical Research, Inc
Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine
tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed
conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover
design.
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to terbinafine or any comparable or similar
product.
Locations and Contacts
Gateway Medical Research, Inc., St. Charles, Missouri 63301, United States
Additional Information
Starting date: March 2004
Ending date: April 2004
Last updated: February 5, 2008
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