[Translation] Bioequivalence study of lacosamide tablets (100 mg) in humans
预试验
考察空腹下拉考沙胺片的PK参数,验证血药浓度分析方法及采血时间、采样量、时间间隔等设置合理性,估算个体内变异系数,初步评价两种制剂的生物等效性。
正式试验
考察受试制剂和参比制剂在空腹及餐后状态下单次给药的PK参数及BA,评价两制剂是否等效。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Preliminary test
Investigate the PK parameters of lacosamide tablets under fasting conditions, verify the rationality of the blood drug concentration analysis method and the blood collection time, sampling volume, time interval, etc., estimate the intra-individual coefficient of variation, and preliminarily evaluate the bioequivalence of the two preparations.
Formal test
Investigate the PK parameters and BA of the test preparation and the reference preparation in the fasting and postprandial state of single administration, and evaluate whether the two preparations are equivalent. At the same time, evaluate the safety and tolerability of the two preparations in healthy humans.
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