[Translation] This was a single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation, isavuconazole sulfate capsules (strength: 100 mg based on C22H17F2N5OS) and the reference formulation, isavuconazole sulfate capsules (Kangxinbo®) (strength: 100 mg based on C22H 17F2N5OS) in healthy adult participants under fasting and fed conditions.
主要试验目的:
研究空腹和餐后状态下单次口服受试制剂硫酸艾沙康唑胶囊(规格:按C22H17F2N5OS 计100mg,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(康新博 ® ,规格:按C22H17F2N5OS计100mg;Swiss Co Services AG生产)在健康参与者体内的药代动力学特征,评价空腹和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:按C22H17F2 N5OS 计100mg)和参比制剂硫酸艾沙康唑胶囊(康新博 ® )(规格:按C22H17F2N5OS 计100mg)在健康参与者中的安全性。
[Translation] Primary study objectives:
To study the pharmacokinetic characteristics of a single oral dose of the test preparation isavuconazole sulfate capsule (specification: 100 mg based on C22H17F2N5OS, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation isavuconazole sulfate capsule (Kangxinbo ® , specification: 100 mg based on C22H17F2N5OS; produced by Swiss Co Services AG) in healthy participants under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations in fasting and fed conditions.
Secondary study objectives:
To study the safety of the test preparation isavuconazole sulfate capsule (specification: 100 mg based on C22H17F2 N5OS) and the reference preparation isavuconazole sulfate capsule (Kangxinbo ® ) (specification: 100 mg based on C22H17F2N5OS) in healthy participants.