[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, two-sequence, double-crossover fasting/fed bioequivalence study of perampanel oral suspension in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂吡仑帕奈口服混悬液(持证商:湖南科伦制药有限公司)与参比制剂吡仑帕奈口服混悬液(持证商:Eisai Europe Limited,商品名:Fycompa®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂吡仑帕奈口服混悬液和参比制剂吡仑帕奈口服混悬液在健康受试者中的安全性。评价受试制剂吡仑帕奈口服混悬液和参比制剂吡仑帕奈口服混悬液的适口性。
[Translation] Primary objective: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation Perampanel Oral Suspension (licensed by Hunan Kelun Pharmaceutical Co., Ltd.) and the reference preparation Perampanel Oral Suspension (licensed by Eisai Europe Limited, trade name: Fycompa®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation Perampanel Oral Suspension and the reference preparation Perampanel Oral Suspension in healthy subjects. To evaluate the palatability of the test preparation Perampanel Oral Suspension and the reference preparation Perampanel Oral Suspension.