[Translation] This study was a single-center, randomized, open-label, double-crossover, two-period, single-dose trial designed in healthy adult subjects to investigate the pharmacokinetic properties of the drug in the fasting or fed state.

考察食物对SOCC-2胶囊药代动力学的影响。评价空腹及餐后口服SOCC-2胶囊的安全性。

[Translation]

To investigate the effect of food on the pharmacokinetics of SOCC-2 capsules and to evaluate the safety of oral administration of SOCC-2 capsules on an empty stomach or after a meal.

Start Date08 Sep 2022

Sponsor / Collaborator

Xiamen Encheng Pharmaceutical Co., Ltd

CTR20222145 / CompletedNot Applicable

本研究为在健康成年受试者中进行的单中心、随机、开放、两周期、两序列、双交叉、多次给药试验设计，评价多次给药的药代动力学研究。

[Translation] This study was a single-center, randomized, open-label, two-period, two-sequence, double-crossover, multiple-dose trial designed to evaluate the pharmacokinetic study of multiple doses in healthy adult subjects.

比较多次口服受试制剂SOCC-2胶囊和参比制剂耐信在健康受试者中药代动力学。评价受试制剂SOCC-2胶囊和参比制剂耐信在健康受试者中的安全性。

[Translation]

To compare the pharmacokinetics of the test preparation SOCC-2 capsules and the reference preparation Nexium after repeated oral administration in healthy subjects. To evaluate the safety of the test preparation SOCC-2 capsules and the reference preparation Nexium in healthy subjects.

Start Date31 Aug 2022

Sponsor / Collaborator

Xiamen Encheng Pharmaceutical Co., Ltd

CTR20211376 / CompletedNot Applicable

本研究为在健康成年受试者中进行的单中心、随机、开放、交叉、多次给药试验设计，评价多次给药状态下的药代动力学和药效学特征。

[Translation] This study was a single-center, randomized, open-label, crossover, multiple-dose trial designed in healthy adult subjects to evaluate the pharmacokinetic and pharmacodynamic characteristics under multiple-dose conditions.

比较多次口服受试制剂SOCC-2胶囊和参比制剂耐信在健康受试者中药代动力学和药效学。

[Translation]

To compare the pharmacokinetics and pharmacodynamics of the test formulation SOCC-2 capsules and the reference formulation Nexium in healthy subjects after repeated oral administration.

Start Date15 Jun 2021

Sponsor / Collaborator

Xiamen Encheng Pharmaceutical Co., Ltd

100 Clinical Results associated with SOCC-2

100 Translational Medicine associated with SOCC-2

100 Patents (Medical) associated with SOCC-2

100 Deals associated with SOCC-2

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal Reflux	Phase 1	CN	Xiamen Encheng Pharmaceutical Co., Ltd	09 Sep 2020
Zollinger-Ellison Syndrome	Phase 1	CN	Xiamen Encheng Pharmaceutical Co., Ltd	09 Sep 2020

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