[Translation] Randomized, open, single-dose, two-sequence, four-cycle, fully repeated cross-over bioequivalence trial clinical research protocol for tacrolimus sustained-release capsules (1mg) in Chinese healthy subjects under fasting and postprandial administration conditions
主要研究目的:按有关生物等效性试验的规定,选择Astellas Pharma Europe B.V.持证的他克莫司缓释胶囊(商品名:新普乐可复,规格:1mg)为参比制剂,对湖南科伦制药有限公司生产提供的受试制剂他克莫司缓释胶囊(规格:1mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂他克莫司缓释胶囊(规格:1mg)和参比制剂他克莫司缓释胶囊(商品名:新普乐可复,规格:1mg)的安全性。
[Translation] The main purpose of the study: According to the relevant bioequivalence test regulations, select Tacrolimus Sustained-release Capsules (trade name: Simpuraq, specification: 1mg) licensed by Astellas Pharma Europe B.V. The test preparation tacrolimus sustained-release capsules (specification: 1mg) produced by Kelun Pharmaceutical Co., Ltd. was administered to humans on an empty stomach and after meals for bioequivalence tests to compare the absorption speed and degree of drug absorption in the test preparation with those of Whether the difference of the reference preparation is within an acceptable range, evaluate the bioequivalence of the two preparations under fasting and fed administration conditions.
Secondary research purposes: To observe the oral administration of the test preparation Tacrolimus sustained-release capsules (specification: 1mg) and the reference preparation Tacrolimus sustained-release capsules (trade name: Simpuraq, specification: 1mg) in healthy subjects. ) for security.