[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of isavuconazole sulfate capsules (100 mg) in Chinese healthy subjects under fasting and fed conditions
主要目的:按有关生物等效性试验的规定,选择SwissCo Services AG生产的硫酸艾沙康唑胶囊(商品名:康新博®,规格:100mg)为参比制剂,对广州市联瑞制药有限公司持证、重庆博腾药业有限公司生产的受试制剂硫酸艾沙康唑胶囊(规格:100mg)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,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要目的:观察健康志愿受试者口服受试制剂硫酸艾沙康唑胶囊(规格:100mg)和参比制剂硫酸艾沙康唑胶囊(商品名:康新博®,规格:100mg)的安全性。
[Translation] Main purpose: According to the relevant provisions of bioequivalence test, isavuconazole sulfate capsules (trade name: Kangxinbo®, specification: 100 mg) produced by SwissCo Services AG were selected as the reference preparation, and the test preparation isavuconazole sulfate capsules (specification: 100 mg) produced by Chongqing Boteng Pharmaceutical Co., Ltd. and licensed by Guangzhou Lianrui Pharmaceutical Co., Ltd. were conducted on fasting and postprandial human bioequivalence tests to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary purpose: To observe the safety of oral administration of the test preparation isavuconazole sulfate capsules (specification: 100 mg) and the reference preparation isavuconazole sulfate capsules (trade name: Kangxinbo®, specification: 100 mg) by healthy volunteers.