[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of moxifloxacin hydrochloride tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸莫西沙星片（规格：0.4g（按C21H24FN3O4计）；生产企业：郑州韩都药业集团有限公司）和参比制剂盐酸莫西沙星片（商品名：拜复乐®（Avelox®）；规格：0.4g（按C21H24FN3O4计）；持证商：Bayer Vital GmbH）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂盐酸莫西沙星片和参比制剂盐酸莫西沙星片（拜复乐®（Avelox®））在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation Moxifloxacin Hydrochloride Tablets (Specification: 0.4g (calculated as C21H24FN3O4); Manufacturer: Zhengzhou Handu Pharmaceutical Group Co., Ltd.) and the reference preparation Moxifloxacin Hydrochloride Tablets (Trade name: Avelox®; Specification: 0.4g (calculated as C21H24FN3O4); Licensee: Bayer Vital GmbH) in Chinese healthy subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. Secondary objective: To observe the safety of the test preparation Moxifloxacin Hydrochloride Tablets and the reference preparation Moxifloxacin Hydrochloride Tablets (Avelox®) in Chinese healthy subjects.

Start Date07 Aug 2024

Sponsor / Collaborator

Zhengzhou Handu Pharmaceutical Co. Ltd.

CTR20241721 / CompletedNot Applicable

富马酸伏诺拉生片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

观察中国健康受试者在空腹/餐后状态下单次口服受试制剂富马酸伏诺拉生片（规格：按 C17H16FN3O2S 计 20mg；生产企业：郑州韩都药业集团有限公司）和参比制剂富马酸伏诺拉生片（商品名：沃克（Vocinti）®；规格：按C17H16FN3O2S 计 20mg ；生产企业： Takeda Pharmaceutical Company Limited,Hikari Plant；持证商：Takeda Pharmaceutical Company Limited）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂富马酸伏诺拉生片和参比制剂富马酸伏诺拉生片（沃克（Vocinti）®）在中国健康受试者中的安全性。

[Translation]

To observe the pharmacokinetic characteristics of the test preparation vonoprazan fumarate tablets (specification: 20 mg based on C17H16FN3O2S; manufacturer: Zhengzhou Handu Pharmaceutical Group Co., Ltd.) and the reference preparation vonoprazan fumarate tablets (trade name: Vocinti®; specification: 20 mg based on C17H16FN3O2S; manufacturer: Takeda Pharmaceutical Company Limited, Hikari Plant; licensee: Takeda Pharmaceutical Company Limited) in Chinese 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 objective: To observe the safety of the test preparation vonoprazan fumarate tablets and the reference preparation vonoprazan fumarate tablets (Vocinti®) in Chinese healthy subjects.

Start Date12 Jun 2024

Sponsor / Collaborator

Zhengzhou Handu Pharmaceutical Co. Ltd.

CTR20234183 / CompletedNot Applicable

乙酰半胱氨酸颗粒在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of acetylcysteine granules in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂乙酰半胱氨酸颗粒（规格：0.2g；生产企业：郑州韩都药业集团有限公司）和参比制剂乙酰半胱氨酸颗粒（商品名：富露施®；规格：0.2g；生产企业：海南赞邦制药有限公司）后的药代动力学特征，初步评价空腹/餐后状态下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颗粒和参比制剂乙酰半胱氨酸颗粒（富露施®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation acetylcysteine granules (specification: 0.2g; manufacturer: Zhengzhou Handu Pharmaceutical Group Co., Ltd.) and the reference preparation acetylcysteine granules (trade name: Fulushi®; specification: 0.2g; manufacturer: Hainan Zanbang Pharmaceutical Co., Ltd.) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation acetylcysteine granules and the reference preparation acetylcysteine granules (Fulushi®) in Chinese healthy subjects.

Start Date19 Jan 2024

Sponsor / Collaborator

Zhengzhou Handu Pharmaceutical Co. Ltd.

100 Clinical Results associated with Zhengzhou Handu Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Zhengzhou Handu Pharmaceutical Co. Ltd.

100 Deals associated with Zhengzhou Handu Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Zhengzhou Handu Pharmaceutical Co. Ltd.

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