[Translation] Human Bioequivalence Study of Lacosamide Tablets (100 mg)
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] pre-test
To investigate the PK parameters of fasting lacosamide tablets, verify the rationality of the blood concentration analysis method and the setting of 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
The PK parameters and BA of a single dose of the test preparation and the reference preparation in fasting and postprandial states were investigated to evaluate whether the two preparations were equivalent. Both formulations were evaluated simultaneously for safety and tolerability in healthy humans.
100 Clinical Results associated with Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd.