[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-crossover, bioequivalence study of dotenoradine tablets in healthy trial participants in both fasting and postprandial settings.
主要研究目的:以河北华晨药业集团有限公司持有的多替诺雷片为受试制剂,以株式会社富士薬品持证的多替诺雷片(商品名:URECE®,规格:2 mg)为参比制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉临床试验来评价两种制剂在空腹及餐后条件下的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康试验参与者中的安全性
[Translation] Primary objective: To evaluate the bioequivalence of dotenorazole tablets (licensed by Hebei Huachen Pharmaceutical Group Co., Ltd.) under fasting and postprandial conditions using dotenorazole tablets (trade name: URECE®, strength: 2 mg) (licensed by Fuji Pharmaceutical Co., Ltd.) as the test formulation and dotenorazole tablets (trade name: URECE®, strength: 2 mg) as the reference formulation in a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover clinical trial.
Secondary objective: To observe the safety of the test and reference formulations in healthy trial participants.