|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date05 Jul 2004 |
/ CompletedNot Applicable [Translation] Comparative study on the pharmacokinetics of upadacitinib sustained-release tablets in human subjects
本研究旨在研究空腹状态下单次口服受试制剂(T)乌帕替尼缓释片(规格:按C17H19F3N6O计15 mg)与参比制剂(R)乌帕替尼缓释片(规格:按C17H19F3N6O计15 mg)的药代动力学特征,比较受试制剂与参比制剂在健康参与者体内吸收速度和程度的差异。
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of a single oral dose of the test formulation (T) upadacitinib extended-release tablets (strength: 15 mg as calculated in C17H19F3N6O) and the reference formulation (R) upadacitinib extended-release tablets (strength: 15 mg as calculated in C17H19F3N6O) in the fasting state, and to compare the differences in the absorption rate and extent of the test formulation and the reference formulation in healthy participants.
/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of carbocycline-levodopa sustained-release tablets in healthy volunteers
主要目的:比较空腹和餐后给药条件下华润双鹤利民药业(济南)有限公司提供的卡左双多巴缓释片(规格:每片含卡比多巴50 mg和左旋多巴200 mg)与MSD Sharp & Dohme GmbH持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg和左旋多巴200 mg;商品名:Sinemet®/息宁®)在健康人群中吸收程度和速度的差异。次要目的:评价空腹及餐后条件下,华润双鹤利民药业(济南)有限公司提供的卡左双多巴缓释片(规格:每片含卡比多巴50 mg和左旋多巴200 mg)与MSD Sharp & Dohme GmbH持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg和左旋多巴200 mg;商品名:Sinemet®/息宁®)的安全性和耐受性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of carbidopa sustained-release tablets (specification: 50 mg carbidopa and 200 mg levodopa per tablet) provided by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and carbidopa sustained-release tablets (specification: 50 mg carbidopa and 200 mg levodopa per tablet; trade name: Sinemet®/Xining®) certified by MSD Sharp & Dohme GmbH in healthy subjects under fasting and fed conditions. Secondary objective: To evaluate the safety and tolerability of carbidopa sustained-release tablets (specification: 50 mg carbidopa and 200 mg levodopa per tablet) provided by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and carbidopa sustained-release tablets (specification: 50 mg carbidopa and 200 mg levodopa per tablet; trade name: Sinemet®/Xining®) certified by MSD Sharp & Dohme GmbH under fasting and fed conditions.
/ CompletedNot Applicable [Translation] Comparative study on the pharmacokinetics of polyprezinc orally disintegrating tablets in healthy volunteers
本试验旨在研究空腹和餐后状态下单次口服受试制剂T聚普瑞锌口腔崩解片(规格:75 mg)与参比制剂R聚普瑞锌口腔崩解片(规格:75 mg;商品名:Promac® D)的药代动力学特征,比较受试制剂与参比制剂在健康研究参与者体内吸收速度和程度的差异,同时评价空腹试验中聚普瑞锌口腔崩解片在中国健康参与者中的适口性,为聚普瑞锌口腔崩解片用药口感提供依据。
[Translation] The purpose of this study was to investigate the pharmacokinetic characteristics of a single oral administration of the test formulation T polypreg zinc orally disintegrating tablets (strength: 75 mg) and the reference formulation R polypreg zinc orally disintegrating tablets (strength: 75 mg; trade name: Promac® D) in the fasting and fed states, to compare the differences in absorption rate and extent between the test formulation and the reference formulation in healthy study participants, and to evaluate the palatability of polypreg zinc orally disintegrating tablets in healthy Chinese participants in the fasting study, so as to provide a basis for the taste of polypreg zinc orally disintegrating tablets.
100 Clinical Results associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
0 Patents (Medical) associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
100 Deals associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
100 Translational Medicine associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.