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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date02 May 1975 |
[Translation] Study on the bioequivalence of carbocycline-levodopa sustained-release tablets in healthy volunteers
主要目的:
采用单中心、随机、开放、自身交叉、单剂量、空腹三周期及餐后两周期给药设计,比较南京兰铭医疗科技有限公司委托精华制药集团股份有限公司生产的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg)与MSD Pharma(Singapore) Pte. Ltd.持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,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,南京兰铭医疗科技有限公司委托精华制药集团股份有限公司生产的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg)与MSD Pharma(Singapore) Pte. Ltd.持证的卡左双多巴缓释片(规格:每片含卡比多巴50 mg,左旋多巴200 mg;商品名:Sinemet®/息宁®)的安全性和耐受性。
[Translation] Main purpose:
Using a single-center, randomized, open, self-crossover, single-dose, three-cycle fasting and two-cycle postprandial dosing design, compare the differences in absorption degree and speed of the carbidopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Nanjing Lanming Medical Technology Co., Ltd. and the carbidopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa; trade name: Sinemet®/Xining®) certified by MSD Pharma (Singapore) Pte. Ltd. in healthy people.
Secondary objective: To evaluate the safety and tolerability of the carbidopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Nanjing Lanming Medical Technology Co., Ltd. and the carbidopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa; trade name: Sinemet®) produced by MSD Pharma (Singapore) Pte. Ltd. under fasting and postprandial conditions.
100 Clinical Results associated with Nanjing Lanming Medical Technology Co., Ltd.
0 Patents (Medical) associated with Nanjing Lanming Medical Technology Co., Ltd.
100 Deals associated with Nanjing Lanming Medical Technology Co., Ltd.
100 Translational Medicine associated with Nanjing Lanming Medical Technology Co., Ltd.