[Translation] A single-center, randomized, open-label, single-dose, complete repeat study to evaluate the bioequivalence of sodium valproate tablets in healthy subjects
主要目的:考察空腹条件下单次口服上海青平药业有限公司生产的丙戊酸钠片(0.2g/片)与协和发酵麒麟株式会社生产的丙戊酸钠片(商品名:DEPAKENE®,200mg/片)的药动学特征,比较其相对生物利用度,评价两制剂间的生物等效性。
次要目的:观察单次口服0.2g的受试制剂丙戊酸钠片或参比制剂(商品名:DEPAKENE®,200mg/片)在健康受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of sodium valproate tablets (0.2 g/tablet) produced by Shanghai Qingping Pharmaceutical Co., Ltd. and sodium valproate tablets (trade name: DEPAKENE®, 200 mg/tablet) produced by Kyowa Hakko Kirin Co., Ltd. under fasting conditions, to compare their relative bioavailability, and to evaluate the bioequivalence between the two preparations.
Secondary objective: To observe the safety of a single oral administration of 0.2 g of the test preparation sodium valproate tablets or the reference preparation (trade name: DEPAKENE®, 200 mg/tablet) in healthy subjects.