[Translation] A single-center, randomized, open-label, single-dose subcutaneous injection, two-formulation, two-sequence, two-period, crossover human fasting bioequivalence study of exenatide injection in healthy Chinese subjects
主要目的:观察中国健康受试者在空腹状态下单次皮下注射受试制剂艾塞那肽注射液10μg(规格:2.4ml:0.6mg,1支/盒;青海晨菲制药有限公司生产并提供)和参比制剂艾塞那肽注射液10μg(商品名:百泌达®;规格:0.25mg/ml,2.4ml/支;1支/盒;Baxter Pharmaceutical Solutions LLC.生产;青海晨菲制药有限公司提供)后的药代动力学特征,评价空腹状态下两制剂的生物等效性。
次要目的:观察受试制剂艾塞那肽注射液和参比制剂艾塞那肽注射液(百泌达®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of a single subcutaneous injection of the test preparation exenatide injection 10 μg (specification: 2.4 ml: 0.6 mg, 1 vial/box; produced and provided by Qinghai Chenfei Pharmaceutical Co., Ltd.) and the reference preparation exenatide injection 10 μg (trade name: Byetta®; specification: 0.25 mg/ml, 2.4 ml/vial; 1 vial/box; produced by Baxter Pharmaceutical Solutions LLC.; provided by Qinghai Chenfei Pharmaceutical Co., Ltd.) in healthy Chinese subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations under fasting conditions.
Secondary objective: To observe the safety of the test preparation exenatide injection and the reference preparation exenatide injection (Byeetta®) in healthy Chinese subjects.