[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-period, crossover bioequivalence study of clofazimine soft capsules in healthy subjects under fasting condition
主要目的:比较空腹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] Primary objective: To compare the pharmacokinetics of a single fasting oral dose of the test clofazimine soft capsule (specification: 100 mg, produced by Dong-A ST Co., Ltd., provided by Sino-Kailin Health Industry (Hainan) Co., Ltd.) and a reference clofazimine soft capsule (trade name: Lamprene®, specification: 100 mg, licensee: Novartis) in healthy Chinese subjects, and to evaluate the bioequivalence of the test clofazimine soft capsule and the reference preparation. Secondary objective: To evaluate the safety of clofazimine soft capsule by observing the safety indicators of the test and reference preparations after a single oral dose in healthy subjects.