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MechanismHIF-PHs inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date29 Jun 2020 |
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of eletodextrin tablets
主要目的:
本研究以烟台东诚大洋制药有限公司研发的艾托格列净片[规格:5 mg(按C22H25ClO7计)]为受试制剂,按生物等效性研究的有关规定,以Merck Sharp & Dohme B.V.持证的艾托格列净片[规格:5 mg(以艾托格列净计),商品名:捷诺妥®/STEGLATRO®]为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要目的:
观察受试制剂艾托格列净片和参比制剂艾托格列净片(捷诺妥®/STEGLATRO®)在健康试验参与者中的安全性。
[Translation] Primary Objective: This study used eltogliflozin tablets [5 mg (calculated as C22H25ClO7)] developed by Yantai Dongcheng Dayang Pharmaceutical Co., Ltd. as the test formulation, and eltogliflozin tablets [5 mg (calculated as eltogliflozin), brand name: STEGLATRO®] certified by Merck Sharp & Dohme B.V. as the reference formulation, in accordance with relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations after administration under fasting conditions.
Secondary Objective: To observe the safety of the test and reference formulations, eltogliflozin tablets (STEGLATRO®), in healthy trial participants.
比较达普司他片与达依泊汀α注射液治疗血液透析慢性肾脏病患者贫血的有效性和安全性的 Ⅲ 期临床研究
[Translation] A Phase III clinical trial comparing the efficacy and safety of dapoxetine tablets and dapoxetine alpha injection in the treatment of anemia in patients with chronic kidney disease undergoing hemodialysis.
主要目的:与达依泊汀α注射液相比,评价达普司他治疗肾性贫血(血液透析)的有效性。
次要目的:评价达普司他治疗肾性贫血(血液透析)的安全性。
评价达普司他对铁代谢的影响。
[Translation] Primary objective: To evaluate the efficacy of dapoxetine (Dapoxetine Alpha) in treating renal anemia (hemodialysis) compared with dapoxetine (Dapoxetine Alpha) injection.
Secondary objective: To evaluate the safety of dapoxetine in treating renal anemia (hemodialysis).
To evaluate the effect of dapoxetine on iron metabolism.
/ CompletedNot Applicable [Translation] Bioequivalence study of dapoxetine tablets
主要目的
比较空腹和餐后给药条件下,山东百诺医药股份有限公司提供的达普司他片(4mg)与グラクソ·スミスクライン株式会社持证的达普司他片(4mg;商品名:Duvroq)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,山东百诺医药股份有限公司提供的达普司他片(4mg)与グラクソ·スミスクライン株式会社持证的达普司他片(4mg;商品名:Duvroq)在健康成年人群中的安全性。
[Translation] Primary Objective
To compare the extent and rate of absorption of dapoxetine tablets (4 mg) provided by Shandong Bio-Pharmaceutical Co., Ltd. and dapoxetine tablets (4 mg, trade name: Duvroq) licensed by Gracso Smythcraft Co., Ltd. in healthy adults under fasting and fed conditions, and to evaluate their bioequivalence.
Secondary Objective
To evaluate the safety of dapoxetine tablets (4 mg) provided by Shandong Bio-Pharmaceutical Co., Ltd. and dapoxetine tablets (4 mg, trade name: Duvroq) licensed by Gracso Smythcraft Co., Ltd. in healthy adults under fasting and fed conditions.
100 Clinical Results associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.
100 Deals associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Yantai Dongcheng Dayang Pharmaceutical Co. Ltd.