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)
Sponsored by: Roxane Laboratories
Official(s) and/or principal investigator(s):
Steven Herrmann, MD, Principal Investigator, Affiliation: Gateway Medical Research, Inc
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
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
Minimum age: 18 Years.
Maximum age: 45 Years.
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
- 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
Locations and Contacts
Gateway Medical Research, Inc., St. Charles, Missouri 63301, United States
Starting date: March 2004
Ending date: April 2004
Last updated: February 5, 2008