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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable 非奈利酮片在健康受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验。
[Translation] An open, randomized, crossover bioequivalence trial of finerenone tablets in healthy subjects under fasting/fed conditions.
主要试验目的:研究空腹/餐后状态下单次口服受试制剂非奈利酮片(规格:20mg,浙江贝得药业有限公司生产)与参比制剂非奈利酮片(商品名:Kerendia®;规格:20mg;Bayer AG生产)在健康受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要试验目的:评估受试制剂非奈利酮片(规格:20mg)与参比制剂非奈利酮片(商品名:Kerendia®,规格:20mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation finerenone tablets (specification: 20 mg, produced by Zhejiang Beide Pharmaceutical Co., Ltd.) and the reference preparation finerenone tablets (trade name: Kerendia®; specification: 20 mg; produced by Bayer AG) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study is to evaluate the safety of the test preparation finerenone tablets (specification: 20 mg) and the reference preparation finerenone tablets (trade name: Kerendia®, specification: 20 mg) in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of lacidipine tablets in humans under fed conditions
考察餐后条件下,健康受试者单次口服由浙江贝得药业有限公司提供的拉西地平片(受试制剂T,规格:6mg)与单次口服由GlaxoSmithKline S.p.A.持证的拉西地平片(参比制剂R,商品名:Lacipil®,规格:6mg)的药动学特征,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral dose of lacidipine tablets (test preparation T, strength: 6 mg) provided by Zhejiang Beide Pharmaceutical Co., Ltd. and a single oral dose of lacidipine tablets (reference preparation R, trade name: Lacipil®, strength: 6 mg) certified by GlaxoSmithKline S.p.A. in healthy subjects under postprandial conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
/ Active, not recruitingNot Applicable 阿奇霉素分散片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of azithromycin dispersible tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服1片浙江贝得药业有限公司生产的阿奇霉素分散片(受试制剂T,规格:0.25g)与相同条件下单次口服1片由Teva Nederland B.V.持证的阿奇霉素片(参比制剂R,商品名:Azitromycin 250mg TEVA,规格:0.25g)的药动学特征,评价两制剂间的生物等效性及安全性。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of azithromycin dispersible tablets produced by Zhejiang Beide Pharmaceutical Co., Ltd. (test preparation T, specification: 0.25 g) and a single oral administration of azithromycin tablets certified by Teva Nederland B.V. (reference preparation R, trade name: Azitromycin 250 mg TEVA, specification: 0.25 g) in healthy subjects under fasting and postprandial conditions, and to evaluate the bioequivalence and safety of the two preparations.
100 Clinical Results associated with Zhejiang Better Pharmaceuticals Co. Ltd.
0 Patents (Medical) associated with Zhejiang Better Pharmaceuticals Co. Ltd.
100 Deals associated with Zhejiang Better Pharmaceuticals Co. Ltd.
100 Translational Medicine associated with Zhejiang Better Pharmaceuticals Co. Ltd.