[Translation] A formal trial of a randomized, open-label, single-dose, two-formulation, two-sequence, crossover controlled design to evaluate the bioequivalence of a single oral dose of the test formulation, perindopril indapamide tablets, and the reference formulation, perindopril indapamide tablets (trade name: Bipro®) in healthy Chinese subjects under fasting and fed conditions
观察健康受试者空腹及餐后状态下单剂量口服受试制剂培哚普利吲达帕胺片(规格:培哚普利叔丁胺4mg,吲达帕胺1.25mg,持证商:呋欧医药科技(湖州)有限公司)后血药浓度的经时过程,估算相应的药代动力学参数,并以培哚普利吲达帕胺片(商品名:百普乐®,规格:培哚普利叔丁胺4mg,吲达帕胺1.25mg,持证商:施维雅(天津)制药有限公司)为参比制剂,进行人体生物等效性正式试验,为该药注册申报和临床应用提供参考依据
[Translation] The time course of blood drug concentration after a single oral dose of the test preparation Perindopril Indapamide Tablets (Specifications: Perindopril tert-butylamine 4 mg, Indapamide 1.25 mg, licensee: Fuo Pharmaceutical Technology (Huzhou) Co., Ltd.) was observed in healthy subjects in the fasting and postprandial states, and the corresponding pharmacokinetic parameters were estimated. Perindopril Indapamide Tablets (trade name: Bipro®, specifications: Perindopril tert-butylamine 4 mg, Indapamide 1.25 mg, licensee: Servier (Tianjin) Pharmaceutical Co., Ltd.) was used as the reference preparation to conduct a formal human bioequivalence trial to provide a reference basis for the registration and clinical application of the drug.