BIOAVAILABILITY AND BIOEQUIVALENCE EVALUATION OF LOKMAL® (ARTEMETHER-LUMEFANTRINE 80/480 MG FIXED DOSE TABLET): AN EMZOR® PHARMACEUTICAL PRODUCT
Journal Title: European Journal of Pharmaceutical and Medical Research - Year 2018, Vol 5, Issue 10
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.
Authors and Affiliations
Dr. Ezealisiji Kenneth M.
Keywords
Related Articles
- EP ID EP639401
- DOI -
- Views 125
- Downloads 0
MIXED LIGAND COMPLEXES OF Ni(II) AND Cd(II) WITH PHTHALIC ACID OR SUCCINIC ACID AND HETEROCYCLIC AMINES: SYNTHESIS AND CHARACTERIZATION WITH ANTIMICROBIAL STUDY
Mixed ligand complexes of Ni(II) and Cd(II) with phthalic acid or succinic acid and heterocyclic amines have been synthesized. The synthesized complexes were characterized by using elemental analysis, conductometric, mag...
TREATING AMERICA: AN ANALYSIS OF PHARMACOLOGICAL ECONOMICS
Healthcare is a big business, plain and simple. Hospitals, clinics and healthcare providers “sell” their services to consumers. In most business models, competition between businesses typically drives costs down, allowin...
ASCENDANCY OF AGE AND TYPE OF FALL IN INFANTS AND TODDLERS WITH TRAUMATIC HEAD INJURY
Significant cranial changes including developing head size & neural function and suture ossification can be observed among growing children of age up to 4 year. An effect may appeared by these changes in type of head tra...
THE CHALLENGE OF OPEN DEFAECATION (OD) AND COMMUNITY-LED TOTAL SANITATION (CLTS) IN NIGERIA
Recent World Health Organization report ranked Nigeria as number two (2) nation in Open Defaecation (OD). This is affirmed as an environmental nuisance that has over time engaged the attention of both government and non-...
AN ANALYTICAL STUDY ON BALA
Perfect health is the cherished wish of all individuals. Health is affected by various factors like Ahara, Vihara, Vichara etc. Unhealthy practices and sometimes physiological vitiation of Dosha occur in the body resulti...