3
Clinical Trials associated with HY-071221 [Translation] Study on relative bioavailability of HY-071221 oral solution in human body
主要目的:在健康受试者中,考察在空腹/餐后状态下单次口服受试制剂HY-071221口服溶液(规格:20mg/mL,合肥医工医药股份有限公司提供)与参比制剂硫酸羟氯喹片(规格:0.2g/片,Plaquenil®)的人体药代动力学特征,并评价两制剂的人体相对生物
利用度。
次要目的:观察健康受试者单次口服受试制剂和参比制剂的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test preparation HY-071221 oral solution (specification: 20 mg/mL, provided by Hefei Yigong Pharmaceutical Co., Ltd.) and the reference preparation hydroxychloroquine sulfate tablets (specification: 0.2 g/tablet, Plaquenil®) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the relative bioavailability of the two preparations in humans. Secondary objective: To observe the safety of the test preparation and the reference preparation after a single oral administration in healthy subjects.
[Translation] Study on the bioavailability of HY-071221 oral solution in humans
主要目的:在健康受试者中,考察在空腹状态下单次口服受试制剂HY-071221口服溶液(规格:20mg/mL,合肥医工医药股份有限公司提供)与参比制剂硫酸羟氯喹片(规格:0.2g/片,(Plaquenil®))的人体药代动力学特征,并评价两制剂的人体相对生物利用度。
次要目的:观察健康受试者单次口服受试制剂和参比制剂的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test preparation HY-071221 oral solution (specification: 20 mg/mL, provided by Hefei Yigong Pharmaceutical Co., Ltd.) and the reference preparation hydroxychloroquine sulfate tablets (specification: 0.2 g/tablet, (Plaquenil®)) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the relative bioavailability of the two preparations in humans.
Secondary objective: To observe the safety of the test preparation and the reference preparation after a single oral administration in healthy subjects.
HY-071221口服溶液在中国健康受试者中的食物影响研究
[Translation] Food effect study of HY-071221 oral solution in Chinese healthy subjects
主要目的:在健康受试者中,考察高脂饮食对口服HY-071221口服溶液(规格:20mg/mL,合肥医工医药股份有限公司提供)药代动力学的影响。
次要目的:评价空腹和进食高脂饮食状态下,健康受试者口服HY-071221口服溶液的安全性。
[Translation] Primary objective: To investigate the effect of a high-fat diet on the pharmacokinetics of HY-071221 oral solution (specification: 20 mg/mL, provided by Hefei Yigong Pharmaceutical Co., Ltd.) in healthy subjects.
Secondary objective: To evaluate the safety of HY-071221 oral solution in healthy subjects under fasting and high-fat diet conditions.
100 Clinical Results associated with HY-071221
100 Translational Medicine associated with HY-071221
100 Patents (Medical) associated with HY-071221
100 Deals associated with HY-071221