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Drug Highest PhaseApproved |
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First Approval Date01 Jan 1966 |
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Active Indication- |
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date- |
[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.
[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.
头孢托仑匹酯颗粒在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of cefditoren pivoxil granules in fasting and fed subjects
本研究考察健康受试者在空腹及餐后条件下,单次口服由福安药业集团庆余堂制药有限公司生产的头孢托仑匹酯颗粒【受试制剂,规格:50 mg(效价)/0.5 g/袋】或由Meiji Seika Pharma Co., Ltd.持证的头孢托仑匹酯颗粒【参比制剂,商品名:美爱克®,规格:50 mg(效价)/0.5 g/袋】的药动学特征,评价两制剂的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of Cefditoren Pivoxil Granules [test preparation, specification: 50 mg (potency)/0.5 g/bag] produced by Qingyutang Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group or Cefditoren Pivoxil Granules [reference preparation, trade name: Mei Aike®, specification: 50 mg (potency)/0.5 g/bag] certified by Meiji Seika Pharma Co., Ltd. in healthy subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.
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.