[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of metformin hydrochloride tablets (0.85 g) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择MERCK SANTE s.a.s.为持证商的盐酸二甲双胍片（商品名：Glucophage®，规格：850mg）为参比制剂，对石家庄市华新药业有限责任公司生产并提供的受试制剂盐酸二甲双胍片（规格：0.85g）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂盐酸二甲双胍片（规格：0.85g）和参比制剂盐酸二甲双胍片（商品名：Glucophage®，规格：850mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) of MERCK SANTE s.a.s. as the licensee were selected as the reference preparation, and the test preparation metformin hydrochloride tablets (specification: 0.85g) produced and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were conducted on the fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin hydrochloride tablets (specification: 0.85g) and the reference preparation metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) by healthy subjects.

Start Date14 Apr 2025

Sponsor / Collaborator

Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

CTR20250688

/ Active, not recruitingNot Applicable

盐酸二甲双胍片（0.85g）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of metformin hydrochloride tablets (0.85 g) in healthy Chinese subjects after meal administration

主要研究目的：按有关生物等效性试验的规定，选择MERCK SANTE s.a.s.为持证商的盐酸二甲双胍片（商品名：Glucophage®，规格：850mg）为参比制剂，对石家庄市华新药业有限责任公司生产并提供的受试制剂盐酸二甲双胍片（规格：0.85g）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂盐酸二甲双胍片（规格：0.85g）和参比制剂盐酸二甲双胍片（商品名：Glucophage®，规格：850mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) of MERCK SANTE s.a.s. as the licensee were selected as the reference preparation, and the test preparation metformin hydrochloride tablets (specification: 0.85g) produced and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were subjected to postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin hydrochloride tablets (specification: 0.85g) and the reference preparation metformin hydrochloride tablets (trade name: Glucophage®, specification: 850mg) by healthy subjects.

Start Date31 Mar 2025

Sponsor / Collaborator

Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

CTR20244660

/ Active, not recruitingNot Applicable

苯磺酸左氨氯地平片随机、开放、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验

[Translation] A randomized, open-label, two-dose, crossover design formal bioequivalence trial of levamlodipine besylate tablets in Chinese healthy subjects

以石家庄市华新药业有限责任公司提供的苯磺酸左氨氯地平片为受试制剂；并以辉瑞制药有限公司的苯磺酸氨氯地平片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Levoamlodipine Besylate Tablets provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were used as the test preparation, and amlodipine Besylate Tablets produced by Pfizer Pharmaceuticals Co., Ltd. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.

Start Date04 Jan 2025

Sponsor / Collaborator

Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

100 Deals associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.

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