[Translation] A randomized, open-label, single-dose, two-dose, two-sequence, two-cycle, crossover bioequivalence trial of clofazimine soft capsules in healthy subjects in fasting and postprandial states
主要目的:比较空腹和餐后单次口服氯法齐明软胶囊受试制剂(规格:100 mg,Dong-A ST Co., Ltd.生产,中诺凯琳健康产业(海南)有限公司提供)与氯法齐明软胶囊参比制剂(商品名:Lamprene®,规格:100 mg,持证商:Novartis)在中国健康受试者体内的药代动力学,评价氯法齐明软胶囊受试制剂与参比制剂的生物等效性。
次要目的:通过观察健康受试者单次口服受试制剂和参比制剂后的安全性指标,评价氯法齐明软胶囊的安全性。
[Translation] Main purpose: To compare the test preparations of clofazimine soft capsules (specification: 100 mg, produced by Dong-A ST Co., Ltd., provided by Zhongnuo Kailin Health Industry (Hainan) Co., Ltd.) on an empty stomach and after a meal. Pharmacokinetics compared with the reference preparation of clofazimine soft capsules (trade name: Lamprene®, strength: 100 mg, licensee: Novartis) in healthy Chinese subjects, to evaluate the experimental clofazimine soft capsules Bioequivalence of the formulation with the reference formulation.
Secondary objective: To evaluate the safety of clofazimine soft capsules by observing the safety indexes of healthy subjects after a single oral administration of the test preparation and the reference preparation.