|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Switzerland |
First Approval Date01 Jan 1984 |
|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date26 Apr 1951 |
/ Not yet recruitingNot Applicable [Translation] Bioequivalence study of mesalazine enteric-coated tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服美沙拉秦肠溶片受试制剂(规格:0.25g,申办者:葵花药业集团佳木斯鹿灵制药有限公司)和参比制剂(商品名:Salofalk®,规格:0.25g,持证商:DR.FALK PHARAMA GmbH)后的药代动力学特点和生物等效性。
次要研究目的
研究美沙拉秦肠溶片受试制剂(规格:0.25g)和参比制剂(商品名:Salofalk,规格:0.25g)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of mesalazine enteric-coated tablets (specification: 0.25g, applicant: Jiamusi Luling Pharmaceutical Co., Ltd., Sunflower Pharmaceutical Group) and the reference formulation (trade name: Salofalk®, specification: 0.25g, licensee: DR.FALK PHARAMA GmbH) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects.
Secondary study objectives
To study the safety of the test formulation of mesalazine enteric-coated tablets (specification: 0.25g) and the reference formulation (trade name: Salofalk, specification: 0.25g) in healthy Chinese adult subjects.
100 Clinical Results associated with Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.
100 Deals associated with Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.