[Translation] A single-center, randomized, open-label, three-period, partially repeated crossover design to evaluate the bioequivalence of a single fasting or fed oral dose of lansoprazole enteric-coated capsules in healthy Chinese subjects

主要研究目的研究空腹/餐后状态下单次口服受试制剂兰索拉唑肠溶胶囊（规格：30mg/粒，北京红林制药有限公司生产）与参比制剂兰索拉唑肠溶胶囊（商品名：达克普隆®，规格：30mg/粒，天津武田药品有限公司）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的研究受试制剂兰索拉唑肠溶胶囊和参比制剂兰索拉唑肠溶胶囊在健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation Lansoprazole Enteric-coated Capsules (specification: 30 mg/capsule, produced by Beijing Honglin Pharmaceutical Co., Ltd.) and the reference preparation Lansoprazole Enteric-coated Capsules (trade name: Dakopron®, specification: 30 mg/capsule, Tianjin Takeda Pharmaceutical Co., Ltd.) in healthy subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting/fed state. Secondary study objectives To study the safety of the test preparation Lansoprazole Enteric-coated Capsules and the reference preparation Lansoprazole Enteric-coated Capsules in healthy subjects.

Start Date14 Feb 2022

Sponsor / Collaborator

Ocean Star International, Inc.

CTR20211615

/ SuspendedNot Applicable

单中心、随机、开放、双周期、交叉设计（空腹）及单中心、随机、开放、三周期、部分重复交叉设计（餐后）评价中国健康受试者口服兰索拉唑肠溶胶囊的人体生物等效性研究

[Translation] A single-center, randomized, open-label, two-period, crossover design (fasting) and a single-center, randomized, open-label, three-period, partially repeated crossover design (postprandial) study to evaluate the bioequivalence of oral lansoprazole enteric-coated capsules in healthy Chinese subjects

主要研究目的：研究空腹/餐后状态下单次口服受试制剂兰索拉唑肠溶胶囊（规格：30mg/粒，北京红林制药有限公司生产）与参比制剂兰索拉唑肠溶胶囊（商品名：达克普隆®，规格：30mg/粒，天津武田药品有限公司）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：研究受试制剂兰索拉唑肠溶胶囊和参比制剂兰索拉唑肠溶胶囊在健康受试者中的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Lansoprazole Enteric-coated Capsules (Specification: 30 mg/capsule, produced by Beijing Honglin Pharmaceutical Co., Ltd.) and the reference preparation Lansoprazole Enteric-coated Capsules (trade name: Dakopron®, specification: 30 mg/capsule, Tianjin Takeda Pharmaceutical Co., Ltd.) in 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 study objectives: To study the safety of the test preparation Lansoprazole Enteric-coated Capsules and the reference preparation Lansoprazole Enteric-coated Capsules in healthy subjects.

Start Date15 Jul 2021

Sponsor / Collaborator

Ocean Star International, Inc.

CTR20200408

/ CompletedNot Applicable

布洛芬缓释胶囊在人體空腹/餐后状态下的开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] An open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence study of ibuprofen sustained-release capsules in human fasting/postprandial conditions

主要目的：研究空腹/餐后状态下单次口服受试制剂布洛芬缓释胶囊（久保芬，规格：0.3g/粒）与参比制剂布洛芬缓释胶囊（芬必得，规格：0.3g/粒）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要目的：研究受试制剂布洛芬缓释胶囊0.3g和参比制剂“芬必得”0.3g在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation ibuprofen sustained-release capsule (Jiubaofen, specification: 0.3g/capsule) and the reference preparation ibuprofen sustained-release capsule (Fenbid, specification: 0.3g/capsule) in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To study the safety of the test preparation ibuprofen sustained-release capsule 0.3g and the reference preparation "Fenbid" 0.3g in healthy subjects.

Start Date26 Mar 2020

Sponsor / Collaborator

Ocean Star International, Inc.

100 Clinical Results associated with Ocean Star International, Inc.

0 Patents (Medical) associated with Ocean Star International, Inc.

100 Deals associated with Ocean Star International, Inc.

100 Translational Medicine associated with Ocean Star International, Inc.

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