|
|
|
|
Active Indication- |
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date01 Jan 1966 |
/ CompletedNot Applicable [Translation] Bioequivalence study of Lebore tablets
主要研究目的
在健康受试者中空腹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] Main study objectives
To investigate the bioequivalence of the test formulation of Lebrexan tablets (5 mg, produced by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, certified by AEISHI Co., Ltd.) after a single oral administration in healthy subjects under fasting state.
Secondary study objectives
To observe the safety of the test formulation and the reference formulation of Lebrexan tablets in healthy subjects.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of sulindac tablets in healthy volunteers
主要目的:
本研究以福安药业集团庆余堂制药有限公司生产并持有的舒林酸片(规格:0.2 g)为受试制剂,按生物等效性研究的有关规定,以WATSON LABORATORIES INC持有的舒林酸片(规格:200 mg,商品名:Sulindac)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:
观察受试制剂舒林酸片和参比制剂舒林酸片(Sulindac)在健康受试者中的安全性。
[Translation] Main purpose:
This study uses Sulindac Tablets (Specification: 0.2 g) produced and owned by Fu'an Pharmaceutical Group Qingyutang Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, Sulindac Tablets (Specification: 200 mg, trade name: Sulindac) owned by WATSON LABORATORIES INC is used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose:
Observe the safety of the test preparation Sulindac Tablets and the reference preparation Sulindac Tablets (Sulindac) in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence study of cefditoren pivoxil tablets in healthy volunteers
头孢托仑匹酯片在中国健康受试者中单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性试验。
[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover human bioequivalence study of cefditoren pivoxil tablets in healthy Chinese 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.