The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
1 x 250 mg
1 x 250 mg
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Bioequivalence based on Cmax
Time frame: Blood samples collected over 144 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 144 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 144 hour period
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