|
Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is a naturally existing molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer’’s type and proposed for treating Alzheimer’’s disease in pharmacological doses. The purpose of the present study was to evaluate the bioefuivalence of two ALC tablets, $Nicetile^{TM} (Dong-A Pharmaceutical Co.) and $L-Cartin^{TM}$ (Kuhn Il Pharmaceutical Co.), according to the guidelines of Korea Food and Drug Administration (KFDA). The ALC release from the two ALC tablets in vitro was tested using KP VII Apparatus II method in various dissolution media (pH 1.2, 6.0 and 6.8). Twenty six normal male volunteers, 24.46pm3.67 years in age and 64.45pm5.54 kg in body weight, were divided into two groups and a randomized 2times2cross-over study was employed. After one tablet containing 500 mg of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. The dissolution profiles of the two ALC tablets were similar in all the dissolution media. The pharmacokinetic parameters such as AUC_t,;C_{max};and;T_{max} were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t,;C_{max};and;T_{max} between two tablets were 0.35%,;0.93%;and;2.34% respectively, when calculated against the Nicetile^{TM} tablet. The powers (1-beta);for;AUC_t , and Cmax were 98.72%;and;85.48%, respectively. Minimum detectable differences (Delta);at;alpha=0.05;and;1-beta=0.8 were less than 20%,;(e.g.,;13.21%;and;18.42%;for;AUC_t,;and;C_{max} respectively). The 90% confidence intervals were within pm20%;(e.g.,;-7.38sim8.09;and;-9.86sim11.72;for;AUC_t,;and;C_{max}, respectively). These two parameters met the criteria of KFDA for bioequivalence, indicating that L-Cartin^{TM} tablet is bioequivalent to Nicetile^{TM} tablet.
|