BIOAVAILABILITY AND BIOEQUIVALENCE EVALUATION OF LOKMAL® (ARTEMETHER-LUMEFANTRINE 80/480 MG FIXED DOSE TABLET): AN EMZOR® PHARMACEUTICAL PRODUCT

Ezealisiji Kenneth M.*, Ifeyinwa Chijioke-Nwauche, Igbinaduwa Patrick, Chijioke Adonye Nwauche

ABSTRACT

Present design evaluated the bioavailability and bioequivalence of generic product of artemether - lumefantrine (AL) antimalarial fixed dose tablet which presents as Lokmal® 80/480 mg an Emzor® Pharmaceutical brand formulated as a single dose oral tablet. A non – randomized open label single dose study in sixteen healthy Nigerian male subjects was designed. The volunteers were administered one tablet of the product with a fatty meal and 250 ml of table water after overnight fast. Plasma samples were analyzed for artemether and lumefantrine exposure simultaneously using a validated High Performance Liquid Chromatography System. The 90% confidence interval for the ratio of the geometric means of AUC0-t was compared with the established bioequivalence limit. The adjusted geometric mean Cmax for artemether and lumefantrine for Lokmal® and Coartem® (standared), was found to be 1.27, 1.29 μg/ml and 33.99, 34.01 μg/ml respectively. The AUC0-t was found to be 4.3, 4.17 μg.h/ml and 791.76, 792.09 μg.h/ml respectively for Lokmal® against Coartem ®. The 90% Confidence interval of the adjusted geometric mean ratio for the basic pharmacokinetic parameters were found to be within limit of specification 80-125% indicating bioequivalence.

Keywords: Bioequivalence, Pharmacokinetics, Chromatography, artemether, lumefantrine.