[Translation] To evaluate the health effects of the test preparation isavuconazole sulfate capsules (specification: 100 mg based on isavuconazole) and the reference preparation isavuconazole sulfate capsules (CRESEMBA®) (specification: 100 mg based on isavuconazole) Single-center, open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence trial in adult participants in the postprandial state
主要试验目的:研究餐后状态下单次口服受试制剂硫酸艾沙康唑胶囊(规格:以艾沙康唑计100 mg,江苏宣泰药业有限公司生产)与参比制剂硫酸艾沙康唑胶囊(CRESEMBA®,规格:以艾沙康唑计100 mg;Swiss Co Services AG生产)在健康参与者体内的药代动力学特征,评价餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂硫酸艾沙康唑胶囊(规格:以艾沙康唑计100 mg)和参比制剂硫酸艾沙康唑胶囊(CRESEMBA®)(规格:以艾沙康唑计100 mg)在健康参与者中的安全性。
[Translation] Main purpose of the test: To study the difference between the test preparation isavuconazole sulfate capsules (specification: 100 mg based on isavuconazole, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation isavuconazole sulfate in the postprandial state. To evaluate the pharmacokinetic characteristics of azole capsules (CRESEMBA®, specification: 100 mg based on isavuconazole; produced by Swiss Co Services AG) in healthy participants, and to evaluate the bioequivalence of the two oral preparations in the postprandial state.
Secondary trial purpose: To study the test preparation isavuconazole sulfate capsules (specification: 100 mg based on isavuconazole) and the reference preparation isavuconazole sulfate capsules (CRESEMBA®) (specification: based on isavuconazole) 100 mg) safety in healthy participants.