[Translation] A randomized, open-label, single-dose, double-period, self-crossover bioequivalence study of perindopril indapamide tablets in healthy subjects under fasting and fed states
主要研究目的:
以国药集团工业有限公司研制的培哚普利吲达帕胺片(规格:培哚普利叔丁胺盐4 mg,吲达帕胺1.25 mg)为受试制剂,按生物等效性研究的有关规定,与施维雅(天津)制药有限公司生产的培哚普利吲达帕胺片(参比制剂,商品名:百普乐®,规格:培哚普利叔丁胺盐4 mg,吲达帕胺1.25 mg)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要研究目的:
观察培哚普利吲达帕胺片受试制剂和参比制剂(规格:培哚普利叔丁胺盐4 mg,吲达帕胺1.25 mg)在健康受试者中的安全性。
[Translation] Main research purposes:
Perindopril indapamide tablets (specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) developed by Sinopharm Group Industry Co., Ltd. , with Perindopril Indapamide Tablets produced by Servier (Tianjin) Pharmaceutical Co., Ltd. 1.25 mg) to compare the relative bioavailability in healthy humans, and investigate the human bioequivalence of the two preparations.
Secondary research purposes:
To observe the safety of perindopril indapamide tablets test preparation and reference preparation (specification: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) in healthy subjects.