[The pharmacokinetics and bioavailability of a new mexiletine preparation in healthy volunteers].
In the course of this study, both the bioavailability and the most important pharmacokinetic parameters of a newly development mexiletine (CAS 31828-71-4) preparation (Mexiletine-ratiopharm mite, dosage 200 mg of mexiletine) were to be determined in comparison to a commercial reference preparation registered according to the AMG 1976, after single oral administration. For this purpose, the test and the reference preparation were examined in healthy male volunteers according to a randomized, 2-way crossover design. Both preparations entrained maximum plasma 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; the plasma half-life of the test preparation was 7.55, for the reference preparation 7.75 h. The statistical comparison (ANOVA, confidence interval according to Westlake, Pratt-Wilcoxon-Test) of the pharmacokinetic parameters obtained in the study clearly resulted in bioequivalence 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.
Hutt
V
V
LAB Gesellschaft für pharmakologische Untersuchungen mbH & Co., Neu-Ulm.
Pabst
G
G
Salama
Z
Z
Kappler
J
J
Jaeger
H
H
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D008297:Male; D008801:Mexiletine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D008875:Middle Aged
D008801:Mexiletine
Untersuchungen zur Pharmakokinetik und Bioverfügbarkeit einer neuen Mexiletin-Zubereitung an gesunden Freiwilligen.