/ Active, not recruitingNot Applicable 培哚普利氨氯地平片(Ⅲ)在健康参与者中的生物等效性试验(餐后试验)
[Translation] Bioequivalence study of perindopril amlodipine tablets (III) in healthy participants (postprandial trial)
主要目的:本试验旨在研究单剂量餐后口服国药致君(深圳)制药有限公司生产的培哚普利氨氯地平片(Ⅲ)(规格:10mg/5mg)的药代动力学特征,并以Les Laboratoires Servier持证的培哚普利氨氯地平片(Ⅲ)(规格:10mg/5mg,商品名:开素达®)作为参比制剂,比较两制剂的药动学参数,以评价两制剂的人体生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Primary Objective: This study aimed to investigate the pharmacokinetic characteristics of a single-dose oral administration of perindopril amlodipine tablets (III) (10 mg/5 mg) manufactured by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd., with perindopril amlodipine tablets (III) (10 mg/5 mg, brand name: Kaisuda®) certified by Les Laboratoires Servier as the reference formulation. The pharmacokinetic parameters of the two formulations were compared to evaluate their bioequivalence in humans.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable 培哚普利氨氯地平片(Ⅲ)在健康参与者中的生物等效性试验(空腹试验)
[Translation] Bioequivalence study of perindopril amlodipine tablets (III) in healthy participants (fasting test)
主要目的:本试验旨在研究单剂量空腹口服国药致君(深圳)制药有限公司生产的培哚普利氨氯地平片(Ⅲ)(规格:10mg/5mg)的药代动力学特征,并以Les Laboratoires Servier持证的培哚普利氨氯地平片(Ⅲ)(规格:10mg/5mg,商品名:开素达®)作为参比制剂,比较两制剂的药动学参数,以评价两制剂的人体生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Primary Objective: This study aimed to investigate the pharmacokinetic characteristics of a single-dose oral administration of perindopril amlodipine tablets (III) (10mg/5mg) manufactured by Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd., on an empty stomach. Perindopril amlodipine tablets (III) (10mg/5mg, trade name: Kaisuda®), certified by Les Laboratoires Servier, was used as the reference formulation. The pharmacokinetic parameters of the two formulations were compared to evaluate their bioequivalence in humans.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of cefpodoxime proxetil tablets in healthy subjects
[Translation] Bioequivalence study of cefpodoxime proxetil tablets in healthy subjects
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