[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of metformin and empagliflozin tablets (I) in healthy adult Chinese subjects

考察单次口服1片（空腹/餐后）受试制剂二甲双胍恩格列净片（I）（规格：每片含盐酸二甲双胍500 mg与恩格列净5 mg，涿州东乐制药有限公司生产）与参比制剂二甲双胍恩格列净片（I）（商品名：SYNJARDY®，规格：每片含盐酸二甲双胍500 mg与恩格列净5 mg，Boehringer Ingelheim Pharmaceuticals Inc持证）在中国成年健康受试者体内的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要目的：评价单次口服1片受试制剂和参比制剂（空腹/餐后）在中国健康受试者中的安全性。

[Translation]

The relative bioavailability of the test preparation metformin empagliflozin tablets (I) (specification: each tablet contains 500 mg metformin hydrochloride and 5 mg empagliflozin, produced by Zhuozhou Dongle Pharmaceutical Co., Ltd.) and the reference preparation metformin empagliflozin tablets (I) (trade name: SYNJARDY®, specification: each tablet contains 500 mg metformin hydrochloride and 5 mg empagliflozin, licensed by Boehringer Ingelheim Pharmaceuticals Inc) in healthy adult Chinese subjects was investigated, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations was evaluated. Secondary objective: To evaluate the safety of the test preparation and the reference preparation (fasting/after meal) in healthy Chinese subjects after a single oral administration of 1 tablet.

Start Date10 Oct 2024

Sponsor / Collaborator

Zhuozhou Dongle Pharmaceutical Co.,Ltd.

CTR20221273 / CompletedNot Applicable

非布司他片在中国健康受试者中进行的单中心、随机、开放、单次空腹口服给药、两制剂、两序列、两周期、双交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, fasting oral bioequivalence study of febuxostat tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, double-crossover

"主要目的：观察中国健康受试者在空腹状态下单次口服受试制剂非布司他片（规格：40mg；生产企业：涿州东乐制药有限公司）和参比制剂非布司他片[商品名：Feburic（菲布力）®；规格：40mg；生产厂家：TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY]后的药代动力学特征，评价空腹状态下两种制剂的生物等效性。次要目的：观察受试制剂非布司他片和参比制剂非布司他片Feburic（菲布力）®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 Febuxostat tablets (Specification: 40 mg; Manufacturer: Zhuozhou Dongle Pharmaceutical Co., Ltd.) and the reference preparation Febuxostat tablets [Trade name: Feburic®; Specification: 40 mg; Manufacturer: TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY] after a single oral administration in the fasting state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary objective: To observe the safety of the test preparation Febuxostat tablets and the reference preparation Febuxostat tablets Feburic® in healthy Chinese subjects."

Start Date09 Jul 2022

Sponsor / Collaborator

Zhuozhou Dongle Pharmaceutical Co.,Ltd.

CTR20212512 / CompletedNot Applicable

非布司他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、双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 Febuxostat tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, double-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非布司他片（规格：40mg；生产企业：涿州东乐制药有限公司）和参比制剂非布司他片[商品名：Feburic（菲布力）；规格：40mg；生产厂家：TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY]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：观察受试制剂非布司他片和参比制剂非布司他片Feburic（菲布力）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 Febuxostat tablets (specification: 40 mg; manufacturer: Zhuozhou Dongle Pharmaceutical Co., Ltd.) and the reference preparation Febuxostat tablets [trade name: Feburic; specification: 40 mg; manufacturer: TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY] after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation Febuxostat tablets and the reference preparation Febuxostat tablets Feburic in healthy Chinese subjects.

Start Date31 Oct 2021

Sponsor / Collaborator

Zhuozhou Dongle Pharmaceutical Co.,Ltd.

100 Clinical Results associated with Zhuozhou Dongle Pharmaceutical Co.,Ltd.

0 Patents (Medical) associated with Zhuozhou Dongle Pharmaceutical Co.,Ltd.

100 Deals associated with Zhuozhou Dongle Pharmaceutical Co.,Ltd.

100 Translational Medicine associated with Zhuozhou Dongle Pharmaceutical Co.,Ltd.

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