Bioequivalence Between Two Tablets of Lacosamide in Healthy Subjects Under Fasting Condition

Abstract

Bioavailability from different formulations of lacosamide 200 mg film-coated tablets was compared in a bioequivalence study under fasting conditions. The study was single dose, randomized, open label, two-period crossover, with Brazilian males and females healthy subjects. Blood samples were taken during 72 h and plasmatic concentrations were determined using a validated HPLC-MS/MS method. Confidence intervals (CI90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed data. The ratios and 90% CI for the geometric mean test/reference ratios were 96.17% (89.30-103.56%) for Cmax and 98.69% (96.71-100.72%) for AUC0-t. Under fasting condition, the test (lacosamide 200 mg film-coated tablets, Monte Verde S.A.) and reference (Vimpat® 200 mg film-coated tablets, Aesica Pharmaceuticals GmbH) formulations were considered bioequivalent since the 90% CIs for the geometric mean test/reference ratios were within ANVISA’s predetermined range of 80% to 125%.