[Translation] A single-center, randomized, open-label, single-dose, two-sequence, two-period fasting and fasting applesauce-mixed/four-period postprandial, crossover-design bioequivalence study of esomeprazole magnesium enteric-coated capsules in healthy subjects

主要研究目的：研究空腹、空腹撒拌、餐后状态下单次口服受试制剂艾司奥美拉唑镁肠溶胶囊（规格：20mg，广东逸舒制药股份有限公司生产）与参比制剂艾司奥美拉唑镁肠溶胶囊（商品名：NEXIUM®，规格：20mg，持证商：AstraZeneca Pharmaceuticals LP）在健康受试者体内的药代动力学特征，并评价口服两种制剂的生物等效性。次要研究目的：研究受试制剂艾司奥美拉唑镁肠溶胶囊（规格：20mg）和参比制剂艾司奥美拉唑镁肠溶胶囊（商品名：NEXIUM®，规格：20mg）在健康受试者中的安全性。

[Translation]

Main study objectives: To study the pharmacokinetic characteristics of the test preparation esomeprazole magnesium enteric-coated capsules (specification: 20 mg, produced by Guangdong Yishu Pharmaceutical Co., Ltd.) and the reference preparation esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®, specification: 20 mg, licensee: AstraZeneca Pharmaceuticals LP) in healthy subjects after single oral administration under fasting, fasting and postprandial conditions, and to evaluate the bioequivalence of the two oral preparations. Secondary study objectives: To study the safety of the test preparation esomeprazole magnesium enteric-coated capsules (specification: 20 mg) and the reference preparation esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®, specification: 20 mg) in healthy subjects.

Start Date03 Jun 2024

Sponsor / Collaborator

Guangdong Eashu Pharmaceutical Co., Ltd.

CTR20221098

/ CompletedNot Applicable

奥美拉唑肠溶胶囊在健康成年受试者、单中心、随机、开放、空腹条件下、单次给药、两周期、两序列、自身交叉对照生物等效性试验

[Translation] A single-center, randomized, open-label, fasting, single-dose, two-cycle, two-sequence, self-crossover bioequivalence study of omeprazole enteric-coated capsules in healthy adult subjects

主要研究目的：研究空腹状态下单次口服受试制剂奥美拉唑肠溶胶囊（规格：20mg，广东逸舒制药股份有限公司生产）与参比制剂奥美拉唑肠溶胶囊（商品名： Losec，规格：20mg；Astrazeneca Limited持证）在健康受试者体内的药代动力学特征，并评价空腹状态口服两种制剂的生物等效性。次要研究目的：观察在空腹条件下单次口服两制剂在健康受试者中的安全性。

[Translation]

Main study objectives: To study the pharmacokinetic characteristics of the test preparation Omeprazole Enteric-coated Capsules (Specification: 20 mg, produced by Guangdong Yishu Pharmaceutical Co., Ltd.) and the reference preparation Omeprazole Enteric-coated Capsules (Trade name: Losec, Specification: 20 mg; Astrazeneca Limited) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary study objectives: To observe the safety of the two preparations in healthy subjects after a single oral administration under fasting conditions.

Start Date10 May 2022

Sponsor / Collaborator

Guangdong Eashu Pharmaceutical Co., Ltd.

CTR20220627

/ CompletedNot Applicable

奥美拉唑肠溶胶囊在健康成年受试者中餐后状态下单中心、随机、开放、两制剂、四周期、两序列、完全重复交叉的生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, completely repeated crossover bioequivalence study of omeprazole enteric-coated capsules in healthy adult subjects after meals

主要目的：研究餐后状态下单次口服受试制剂奥美拉唑肠溶胶囊（规格：20mg，广东逸舒制药股份有限公司生产）与参比制剂奥美拉唑肠溶胶囊（商品名：Losec，规格：20mg，Astrazeneca Limited持证）在健康受试者体内的药代动力学特征，并评价餐后状态口服两种制剂的生物等效性。次要目的：研究受试制剂奥美拉唑肠溶胶囊（规格：20mg）和参比制剂奥美拉唑肠溶胶囊（商品名：Losec，规格：20mg ）在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of the test preparation Omeprazole Enteric-coated Capsules (Specification: 20 mg, produced by Guangdong Yishu Pharmaceutical Co., Ltd.) and the reference preparation Omeprazole Enteric-coated Capsules (trade name: Losec, specification: 20 mg, licensed by Astrazeneca Limited) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary objective: To study the safety of the test preparation Omeprazole Enteric-coated Capsules (Specification: 20 mg) and the reference preparation Omeprazole Enteric-coated Capsules (trade name: Losec, specification: 20 mg) in healthy subjects.

Start Date17 Mar 2022

Sponsor / Collaborator

Guangdong Eashu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guangdong Eashu Pharmaceutical Co., Ltd.

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

100 Deals associated with Guangdong Eashu Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Guangdong Eashu Pharmaceutical Co., Ltd.

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Guangdong Eashu Pharmaceutical Co., Ltd.

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