[Translation] A randomized, open-label, fasting and postprandial, single-dose, two-cycle, double-crossover bioequivalence trial of stiripentol dry suspension (500 mg) in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择BIOCODEX为生产商的司替戊醇干混悬剂(商品名:Diacomit,规格:500mg/袋)为参比制剂,对石家庄四药有限公司生产的受试制剂司替戊醇干混悬剂(规格:500mg/袋)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的:观察健康志愿受试者口服受试制剂司替戊醇干混悬剂(规格:500mg/袋)和参比制剂司替戊醇干混悬剂(商品名:Diacomit,规格:500mg/袋)的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, the dry suspension of stiripentol (trade name: Diacomit, specification: 500mg/bag) with BIOCODEX as the manufacturer was selected as the reference preparation, which is not suitable for Shijiazhuang Four Drugs Limited. The test preparation stiripentol dry suspension (specification: 500mg/bag) produced by the company was subjected to fasting and postprandial administration to human body bioequivalence test, and the absorption rate and degree of absorption of the drug in the test preparation were compared with the reference Whether the difference between the formulations is within an acceptable range, compare the bioequivalence of the two formulations under fasting and postprandial dosing conditions. Secondary research purpose: To observe healthy volunteers taking the test preparation stiripentol dry suspension (specification: 500mg/bag) and the reference preparation stiripentol dry suspension (trade name: Diacomit, specifications: 500mg/bag) safety.