[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of cyclosporine soft capsules (100 mg) in Chinese healthy participants under fasting conditions
主要研究目的:按有关生物等效性试验的规定,选择Novartis Pharmaceuticals Corporation为持证商的环孢素软胶囊(商品名:NEORAL®,规格:100mg)为参比制剂,人福普克药业(武汉)有限公司生产并提供的受试制剂环孢素软胶囊(规格:100mg)进行空腹给药条件下的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给药条件下的生物等效性。
次要研究目的:观察健康参与者口服受试制剂环孢素软胶囊(规格:100mg)和参比制剂环孢素软胶囊(商品名:NEORAL®,规格:100mg)的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, cyclosporine soft capsules (trade name: NEORAL®, specification: 100 mg) with Novartis Pharmaceuticals Corporation as the licensee were selected as the reference preparation, and the test preparation cyclosporine soft capsules (specification: 100 mg) produced and provided by Renfu Puke Pharmaceutical (Wuhan) Co., Ltd. were used for human bioequivalence test under fasting conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation cyclosporine soft capsules (specification: 100 mg) and the reference preparation cyclosporine soft capsules (trade name: NEORAL®, specification: 100 mg) by healthy participants.