[Translation] Single-center, randomized, open-label, two-agent, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of apremilast tablets 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阿普米司特片(生产厂家:广东隆赋药业股份 有限公司)与参比制剂阿普米司特片(持证商:Amgen Europe B.V.,商 品名:Otezla®)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:观察受试制剂阿普米司特片和参比制剂阿普米司特片在健康 受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, to compare the oral test preparation Apremilast Tablets (manufacturer: Guangdong Longfu Pharmaceutical Co., Ltd.) and the reference preparation in fasting/postprandial state respectively. Pharmacokinetic behavior of apremilast tablets (licenser: Amgen Europe B.V., trade name: Otezla®) in healthy subjects, evaluating the bioequivalence of the two formulations. Secondary objective: To observe the safety of the test preparation Apremilast Tablets and the reference preparation Apremilast Tablets in healthy subjects.