[Translation] A single-center, open-label, randomized, four-period, two-sequence repeated crossover bioequivalence study of a single oral dose of cyclosporine soft capsules in Chinese healthy volunteers under fasting and fed conditions
主要研究目的:研究中国健康受试者在空腹和餐后条件下单次口服受试制剂环孢素软胶囊(50mg)与参比制剂Neoral®(50mg)的药代动力学行为,评价空腹和餐后条件口服两种制剂的生物等效性。
次要研究目的:评价受试制剂环孢素软胶囊(50mg)与参比制剂Neoral®(50mg)在健康人群中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic behavior of the test preparation cyclosporine soft capsule (50 mg) and the reference preparation Neoral® (50 mg) in Chinese healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary purpose of the study is to evaluate the safety of the test preparation cyclosporine soft capsule (50 mg) and the reference preparation Neoral® (50 mg) in healthy people.