Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions
Sponsored by Roxane Laboratories
About this trial
Last updated 7 years ago
Study ID
TERB-01
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 45 Years
All
Trial Timing
Ended 21 years ago
What is this trial about?
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
fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence
crossover design.
What are the participation requirements?
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.