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First Approval Date01 Jan 1966 |
/ CompletedNot Applicable [Translation] Bioequivalence study of Leboresen tablets 5mg
主要研究目的
以福安药业集团庆余堂制药有限公司生产的莱博雷生片(规格:5mg)为受试制剂(T),按有关生物等效性试验的规定,以エーザイ株式会社持证的莱博雷生片(商品名:DAYVIGO®,规格:5mg)为参比制剂(R)进行生物等效性试验。
次要研究目的
观察受试制剂与参比制剂莱博雷生片在健康受试者中的安全性。
[Translation] Primary Study Objective: Using Leboresen tablets (5mg) manufactured by Qingyutang Pharmaceutical Co., Ltd. (a subsidiary of Fu'an Pharmaceutical Group) as the test formulation (T), and following relevant bioequivalence testing regulations, using Leboresen tablets (trade name: DAYVIGO®, 5mg) certified by Aezai Co., Ltd. as the reference formulation (R), a bioequivalence study was conducted.
Secondary Study Objective: To observe the safety of the test and reference formulations of Leboresen tablets in healthy subjects.
/ CompletedNot Applicable [Translation] Oxazepam tablets bioequivalence test
主要研究目的:
以福安药业集团庆余堂制药有限公司持有的奥沙西泮片(规格:15mg)为受试制剂(T),按有关生物等效性试验的规定,以Pfizer AS持证的奥沙西泮片(规格:15mg,商品名:Sobril®)为参比制剂(R)进行生物等效性试验。
次要研究目的:
观察受试制剂奥沙西泮片和参比制剂奥沙西泮片在健康受试者中的安全性。
[Translation] Primary Study Objective: To conduct a bioequivalence study using oxazepam tablets (15mg) manufactured by Qingyutang Pharmaceutical Co., Ltd. (a subsidiary of Fu'an Pharmaceutical Group) as the test formulation (T), and oxazepam tablets (15mg, trade name: Sobril®) manufactured by Pfizer AS as the reference formulation (R), in accordance with relevant bioequivalence study regulations.
Secondary Study Objective: To observe the safety of the test formulation oxazepam tablets and the reference formulation oxazepam tablets in healthy subjects.
/ SuspendedNot Applicable [Translation] Postprandial bioequivalence test of Leborexin tablets
主要研究目的
在健康受试者中餐后状态下分别单次口服莱博雷生片受试制剂(5mg,福安药业集团庆余堂制药有限公司生产)与参比制剂(商品名:DAYVIGO®,5mg,エーザイ株式会社持证)后的生物等效性。
次要研究目的
观察受试制剂与参比制剂莱博雷生片在健康受试者中的安全性。
[Translation] Primary Study Objective: To assess the bioequivalence of a single oral dose of the test formulation (5 mg, manufactured by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, licensed by Aezai Co., Ltd.) of Leborexen tablets in healthy subjects after a meal.
Secondary Study Objective: To observe the safety of the test and reference formulations of Leborexen tablets in healthy subjects.
100 Clinical Results associated with Chongqing Qingyutang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Chongqing Qingyutang Pharmaceutical Co. Ltd.
100 Deals associated with Chongqing Qingyutang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Chongqing Qingyutang Pharmaceutical Co. Ltd.