[Translation] Bioequivalence study of acipimox capsules
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服阿昔莫司胶囊受试制剂(规格:0.25g,申办者:天津掌心医药科技有限公司)和参比制剂(商品名:Olbetam®,规格:0.25g,持证商:Pfizer Limited)后的药代动力学特点和生物等效性。
次要研究目的
研究阿昔莫司胶囊受试制剂(规格:0.25g)和参比制剂(商品名:Olbetam®,规格:0.25g)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of acipimox capsule test formulation (specification: 0.25g, applicant: Tianjin Palm Pharmaceutical Technology Co., Ltd.) and reference formulation (trade name: Olbetam®, specification: 0.25g, licensee: Pfizer Limited) after single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of acipimox capsule test formulation (specification: 0.25g) and reference formulation (trade name: Olbetam®, specification: 0.25g) in healthy Chinese adult subjects.
健康受试者在空腹及餐后状态下单次口服沙库巴曲缬沙坦钠片的人体生物等效性试验
[Translation] Bioequivalence study of a single oral dose of sacubitril-valsartan sodium tablets in healthy volunteers in fasting and fed state
(1)主要目的:以天津掌心医药科技有限公司提供的沙库巴曲缬沙坦钠片为受试制剂(T),以Novartis Pharma Schweiz AG持证,Novartis Farma S.p.A.生产的沙库巴曲缬沙坦钠片(商品名:诺欣妥)为参比制剂(R),评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征,评价两种制剂的人体生物等效性。
(2)次要目的:考察健康受试者口服受试制剂和参比制剂后的安全性。
[Translation] (1) Primary objective: To evaluate the pharmacokinetic characteristics of the test and reference preparations after a single oral administration in healthy subjects in the fasting and postprandial state, using sacubitril-valsartan sodium tablets provided by Tianjin Palm Pharmaceutical Technology Co., Ltd. as the test preparation (T) and sacubitril-valsartan sodium tablets (trade name: Nusintuo) licensed by Novartis Pharma Schweiz AG and produced by Novartis Farma S.p.A. as the reference preparation (R).
(2) Secondary objective: To investigate the safety of the test and reference preparations after oral administration in healthy subjects.
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