EVALUATION OF THE PHARMACOKINETICS AND BI OAVAILABILITY OF A NEW MEXILETINE PREPARATION IN HEALTHY MALE-VOLUNTEERS

Tn the course of this study, both the bioavailability and the most imp ortant pharmacokinetic parameters of a newly development mexiletine (G AS 31828-71-4) preparation (Mexiletine-ratiopharm(R) mite, dosage 200 mg of mexiletine) were to be determined in comparison to a commercial reference preparation registered according to the AMG 1976, after sing le oral administration. For this purpose, the test and the reference p reparation were examined in healthy male volunteers according to a ran domized 2-way crossover design. Both preparations entrained maximum pl asma levels of approx. 300 ng/ml 3.5-4 h following administration. For the areas under the curve, values around 4000 h x ng/ml were found; t he plasma half-life of the test preparation was 7.55, for the referenc e preparation 7.75 h. The statistical comparison (ANOVA, confidence in terval according to Westlake Platt-Wilcoxon-Test) of the pharmacokinet ic parameters obtained in the study, clearly resulted in bioequivalenc e of the newly developed mexiletine preparation and the reference drug . No side effects worth mentioning were observed after administration of either preparation, thus good and comparable clinical tolerability of both preparations may be presumed.