考察健康受试者空腹及餐后单次口服受试制剂盐酸二甲双胍片（广东赛康制药厂有限公司生产，规格：850mg/片）的人体药代动力学特征，并以已上市的盐酸二甲双胍片（商品名：格华止®；Merck Serono生产，规格：850mg/片）为参比制剂，两周期、两交叉设计进行人体生物等效性研究，并观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetic characteristics of the test preparation metformin hydrochloride tablets (produced by Guangdong Saikang Pharmaceutical Factory Co., Ltd., specification: 850 mg/tablet) were investigated in healthy subjects after single oral administration on an empty stomach or after meals. The marketed metformin hydrochloride tablets (trade name: Glucophage®; produced by Merck Serono, specification: 850 mg/tablet) were used as the reference preparation. A two-period, two-crossover design was used to conduct a human bioequivalence study, and the safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date07 Mar 2018

Sponsor / Collaborator

Guangdong SinocorpPharmaceutical Co., Ltd.

CTR20180097

/ CompletedNot Applicable

盐酸二甲双胍片人体生物等效性试验（预试验）

[Translation] Bioequivalence study of metformin hydrochloride tablets in humans (preliminary study)

考察健康受试者空腹及餐后单次口服受试制剂盐酸二甲双胍片（广东赛康制药厂有限公司生产，规格：850mg/片）的人体药代动力学特征，并以盐酸二甲双胍片（Merck Serono生产，规格：850mg/片）为参比制剂，进行人体生物等效性研究，并观察受试制剂和参比制剂在健康受试者中的安全性。为正式试验的样本量计算和采血点设计提供可靠依据。

[Translation]

The human pharmacokinetic characteristics of the test preparation metformin hydrochloride tablets (manufactured by Guangdong Saikang Pharmaceutical Factory Co., Ltd., specification: 850mg/tablet) were investigated in healthy subjects after single oral administration on an empty stomach and after meals, and metformin hydrochloride tablets (manufactured by Merck Serono, specification: 850mg/tablet) were used as the reference preparation for human bioequivalence study, and the safety of the test preparation and reference preparation in healthy subjects was observed. This provides a reliable basis for the sample size calculation and blood sampling point design of the formal trial.

Start Date23 Jan 2018

Sponsor / Collaborator

Guangdong SinocorpPharmaceutical Co., Ltd.

CTR20171595

/ CompletedNot Applicable

盐酸二甲双胍缓释片随机、开放、两周期、两交叉单次空腹及餐后状态下人体生物等效性试验（预试验）

[Translation] A randomized, open, two-period, two-crossover single fasting and fed human bioequivalence study of metformin hydrochloride extended-release tablets (preliminary study)

考察健康受试者空腹及餐后单次口服受试制剂盐酸二甲双胍缓释片（商品名：元唐；广东赛康制药厂有限公司生产，规格：500mg/片）的人体药代动力学特征，并以盐酸二甲双胍缓释片（商品名：Glucophage XR；百时美施贵宝公司生产，规格：500mg/片）为参比制剂，两周期两交叉设计进行人体生物等效性研究，并观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetic characteristics of the test preparation metformin hydrochloride sustained-release tablets (trade name: Yuan Tang; produced by Guangdong Saikang Pharmaceutical Factory Co., Ltd., specification: 500 mg/tablet) were investigated in healthy subjects after a single oral administration on an empty stomach or after a meal. Metformin hydrochloride sustained-release tablets (trade name: Glucophage XR; produced by Bristol-Myers Squibb, specification: 500 mg/tablet) were used as the reference preparation. A two-period, two-crossover design was used to conduct a human bioequivalence study, and the safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date21 Jan 2018

Sponsor / Collaborator

Guangdong SinocorpPharmaceutical Co., Ltd.

100 Clinical Results associated with Guangdong SinocorpPharmaceutical Co., Ltd.

0 Patents (Medical) associated with Guangdong SinocorpPharmaceutical Co., Ltd.

100 Deals associated with Guangdong SinocorpPharmaceutical Co., Ltd.

100 Translational Medicine associated with Guangdong SinocorpPharmaceutical Co., Ltd.

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