Pharmacokinetics and Relative Bioavailability of Lammortrigine Tablets in Healthy Volunteers

OBJECTIVE: To study pharmacokinetics and relative bioavailability of domestic lammortrigine tablets in 20 healthy male volunteers. METHODS: A single oral at the dose of 25 mg domestic lammortrigine and lamictal were administrated according to randomized-cross design. The lammortrigine in plasma was detected by HPLC. RESULTS: The pharmacokinetic parameters of lamictal and domestic lammortrigine were as followings: C_(max) were 350.1± 68.6 and 351.9±53.9 μg·L~(-1),t_(max) were 3.1±2.2 and 2.7±1.9 h, CL/F were 1.50±0.41 and 1.59±0.46 L·h~(-1), t_(1/2) were38.7±12.1 and38.0 ±9.3h, AUC_(0→144) were 16.62±5.05 and 15.75±4.75 mg·h·L~(-1), and AUC_(0→∞) were 18.27±6.87 and 17.15±5.78 mg·h·L~(-1), respectively. The difference of those parameters had no statistic significance between the two formulations (P 0.05). The extent of relative bioavailability (F) of domestic lammortrigine, based on the AUC_(0·144) data, was (95.2±9.2)%, with a 90% confidence interval of 91.6% - 98.8%. CONCLUSION: The result showed that the two formulations are bioequivalent.