[Translation] Single-dose, two-period, double-crossover bioequivalence study of clobazam oral suspension (10 mg/5 mL and 2.5 mg/mL, 20 mg) in healthy subjects under fasting and fed conditions
考察空腹及餐后条件下单次口服20mg由上海爱的发制药有限公司提供的氯巴占口服混悬液(受试制剂,商品名:Tapclob®,规格:10mg/5mL)或单次口服20mg由Lundbeck Pharmaceuticals LLC持证的氯巴占口服混悬液(参比制剂,商品名:Onfi®,规格:2.5mg/mL)的生物等效性。
[Translation] The bioequivalence of a single oral dose of 20 mg of clobazam oral suspension provided by Shanghai Aifa Pharmaceutical Co., Ltd. (test preparation, trade name: Tapclob®, strength: 10 mg/5 mL) or a single oral dose of 20 mg of clobazam oral suspension certified by Lundbeck Pharmaceuticals LLC (reference preparation, trade name: Onfi®, strength: 2.5 mg/mL) was investigated under fasting and postprandial conditions.