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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date26 Feb 2020 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date31 Jan 2013 |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable 布洛芬混悬液在中国健康成年试验参与者中的生物等效性试验
[Translation] Bioequivalence study of ibuprofen suspension in healthy adult participants in China
主要研究目的:
健康试验参与者空腹状态下,单次口服江西施美药业股份有限公司生产的受试制剂布洛芬混悬液(规格:100 ml:2g)或上海强生制药有限公司生产的参比制剂布洛芬混悬液(商品名:美林®(Motrin®);规格:100 ml:2g),考察空腹状态下受试制剂与参比制剂在健康试验参与者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
考察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetic parameters of the test formulation ibuprofen suspension (100 ml: 2 g) manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd., or the reference formulation ibuprofen suspension (trade name: Motrin®; 100 ml: 2 g) manufactured by Shanghai Johnson & Johnson Pharmaceutical Co., Ltd., in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Objective: To investigate the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable JSS-221在中国健康试验参与者中的生物等效性试验
[Translation] JSS-221 Bioequivalence Trial in Chinese Health Trial Participants
主要研究目的
健康试验参与者空腹或餐后状态下,单次口服江西施美药业股份有限公司生产的受试制剂JSS-221(规格:10mg/片)或H. Lundbeck A/S生产的参比制剂氢溴酸伏硫西汀片(商品名:心达悦;规格:10mg/片),分别考察空腹或餐后状态下受试制剂与参比制剂在健康试验参与者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的
考察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] Primary Study Objective: To investigate the pharmacokinetic parameters of the test formulation JSS-221 (10 mg/tablet) manufactured by Jiangxi Shimei Pharmaceutical Co., Ltd., or the reference formulation vortioxetine hydrobromide tablets (trade name: Xindayue; 10 mg/tablet) manufactured by H. Lundbeck A/S, in healthy participants under fasting or postprandial conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Study Objective: To investigate the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of dotenoradine tablets in healthy adult participants in China
主要研究目的:研究空腹/餐后状态下口服受试制剂与参比制剂在中国健康成年参与者体内的药代动力学特征,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:评估受试制剂和参比制剂在中国健康成年参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of the test formulation and the reference formulation in healthy adult participants in China under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions. Secondary objective: To assess the safety of the test formulation and the reference formulation in healthy adult participants in China.
100 Clinical Results associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Deals associated with Jiangxi Shimei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangxi Shimei Pharmaceutical Co., Ltd.