/ CompletedNot Applicable 培哚普利氨氯地平片(III)在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of perindopril amlodipine tablets (III) in Chinese healthy volunteers under fasting and fed conditions
观察受试制剂培哚普利氨氯地平片(III)(规格:10mg/5mg)和参比制剂培
哚普利氨氯地平片(III)(开素达®,规格:10mg/5mg)在中国健康受试者中单次
口服给药后的体内动力学过程, 估算相应的药代动力学参数, 并以Les
Laboratoires Servier持证原研进口上市的培哚普利氨氯地平片(III)(开素达®)为
参比制剂,进行生物等效性评价。
次要目的:
观察受试制剂培哚普利氨氯地平片(III)和参比制剂培哚普利氨氯地平片(III)
在中国健康受试者中的安全性。
[Translation] To observe the in vivo kinetics of the test preparation Perindopril Amlodipine Tablets (III) (Specification: 10mg/5mg) and the reference preparation Perindopril Amlodipine Tablets (III) (Kesoda®, Specification: 10mg/5mg) after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and use the Perindopril Amlodipine Tablets (III) (Kesoda®) licensed and imported by Les Laboratoires Servier as the reference preparation for bioequivalence evaluation.
Secondary objective:
To observe the safety of the test preparation Perindopril Amlodipine Tablets (III) and the reference preparation Perindopril Amlodipine Tablets (III) in healthy Chinese subjects.
/ CompletedNot Applicable 吲哚布芬片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of indobufen tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:观察吲哚布芬片在中国健康受试者中单次口服给药后吲哚布芬的体内动力学过程,估算相应的药代动力学参数,并以Pfizer Italia S.r.l 持证的的吲哚布芬片IBUSTRIN ®为参比制剂,进行生物等效性评价。
次要目的:观察吲哚布芬片受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective: To observe the in vivo kinetics of indobufen tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and conduct bioequivalence evaluation using IBUSTRIN®, a certified indobufen tablet from Pfizer Italia S.r.l., as the reference preparation.
Secondary objective: To observe the safety of the test preparation and reference preparation of indobufen tablets in healthy humans.
100 Clinical Results associated with Shenzhen Langbo Biological Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shenzhen Langbo Biological Pharmaceutical Co., Ltd.
100 Deals associated with Shenzhen Langbo Biological Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shenzhen Langbo Biological Pharmaceutical Co., Ltd.