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头孢托仑匹酯颗粒受试制剂【规格：50mg（效价）/0.5g/袋，申办者：广州仁恒医药科技股份有限公司】和参比制剂【商品名：美爱克®，学特点和生物等效性。次要研究目的研究头孢托仑匹酯颗粒受试制剂【规格：50mg（效价）/0.5g/袋】和参比制剂【商品名：美爱克®，规格：50mg（效价）/0.5g/袋】在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the bioequivalence of the single oral dose of cefditoren pivoxil granules [Specification: 50mg (potency)/0.5g/bag, applicant: Guangzhou Yanheng Pharmaceutical Technology Co., Ltd.] and the reference preparation [trade name: Mei Aike®] in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of cefditoren pivoxil granules [Specification: 50mg (potency)/0.5g/bag] and the reference preparation [trade name: Mei Aike®, specification: 50mg (potency)/0.5g/bag] in healthy Chinese adult subjects.

Start Date31 Mar 2025

Sponsor / Collaborator

Renheng Pharm Ltd.

CTR20243385

/ CompletedNot Applicable

乙酰半胱氨酸片（规格：0.6g）与参比制剂乙酰半胱氨酸片（商品名：Fluimucil，规格：600mg）在健康受试者中单中心、随机、开放、两制剂、单次给药、空腹（两周期、双交叉）/餐后（四周期、完全重交叉）生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, fasting (two-cycle, double-crossover)/fed (four-cycle, fully re-crossover) bioequivalence study between acetylcysteine tablets (0.6 g) and reference acetylcysteine tablets (trade name: Fluimucil, 600 mg) in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂乙酰半胱氨酸片（规格：0.6g，持证商：广州仁恒医药科技股份有限公司）与参比制剂乙酰半胱氨酸片（规格：600mg，持证商：Zambon Nederland B.V.）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂乙酰半胱氨酸片和参比制剂乙酰半胱氨酸片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation acetylcysteine tablets (specification: 0.6g, licensee: Guangzhou Yanheng Pharmaceutical Technology Co., Ltd.) and the reference preparation acetylcysteine tablets (specification: 600mg, licensee: Zambon Nederland B.V.) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation acetylcysteine tablets and the reference preparation acetylcysteine tablets in healthy subjects.

Start Date28 Nov 2024

Sponsor / Collaborator

Renheng Pharm Ltd.

CTR20241305

/ CompletedNot Applicable

己酮可可碱缓释片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of pentoxifylline extended-release tablets in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂己酮可可碱缓释片（规格：400mg，持证商：广州仁恒医药科技股份有限公司）与参比制剂己酮可可碱缓释片（规格：400mg，持证商：Sanofi，商品名：Trental®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂己酮可可碱缓释片和参比制剂己酮可可碱缓释片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation pentoxifylline sustained-release tablets (specification: 400 mg, licensee: Guangzhou Yanheng Pharmaceutical Technology Co., Ltd.) and the reference preparation pentoxifylline sustained-release tablets (specification: 400 mg, licensee: Sanofi, trade name: Trental®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation pentoxifylline sustained-release tablets and the reference preparation pentoxifylline sustained-release tablets in healthy subjects.

Start Date12 May 2024

Sponsor / Collaborator

Renheng Pharm Ltd.

100 Clinical Results associated with Renheng Pharm Ltd.

0 Patents (Medical) associated with Renheng Pharm Ltd.

100 Deals associated with Renheng Pharm Ltd.

100 Translational Medicine associated with Renheng Pharm Ltd.

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