一项评价氟比洛芬凝胶贴膏治疗膝骨关节炎有效性和安全性的多中心、随机、盲法、平行分组、阳性药对照、安慰剂对照Ⅲ期临床研究
[Translation] A multicenter, randomized, blinded, parallel-group, active-controlled, placebo-controlled phase III clinical study to evaluate the efficacy and safety of flurbiprofen gel patch in the treatment of knee osteoarthritis
主要目的:以原研药Zepolas®(泽普思)为阳性对照药,评价氟比洛芬凝胶贴膏治疗膝关节骨性关节炎的临床疗效非劣效性;以安慰剂为对照,评价氟比洛芬凝胶贴膏治疗膝关节骨性关节炎的优效性;
次要目的:评价氟比洛芬凝胶贴膏用于膝骨关节炎患者的安全性。
[Translation] Primary objective: To evaluate the non-inferiority of the clinical efficacy of flurbiprofen gel patch in the treatment of knee osteoarthritis using the original drug Zepolas® as the positive control drug; to evaluate the superiority of flurbiprofen gel patch in the treatment of knee osteoarthritis using placebo as the control;
Secondary objective: To evaluate the safety of flurbiprofen gel patch in patients with knee osteoarthritis.
[Translation] Study on the bioequivalence of carbocycline-levodopa sustained-release tablets in healthy volunteers
主要目的:空腹试验采用单中心、随机、开放、单剂量、四周期完全重复交叉设计,餐后试验采用单中心、随机、开放、单剂量、两周期交叉设计,比较海南慧通生物医药科技有限公司委托湖南九典制药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,海南慧通生物医药科技有限公司委托湖南九典制药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 objective: The fasting trial adopted a single-center, randomized, open, single-dose, four-period completely repeated crossover design, and the postprandial trial adopted a single-center, randomized, open, single-dose, two-period crossover design to compare the differences in absorption degree and speed between the carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Hunan Jiudian Pharmaceutical Co., Ltd. and the carbidopa-levodopa 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 carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa) produced by Hunan Jiudian Pharmaceutical Co., Ltd. and carbidopa-levodopa sustained-release tablets (specifications: each tablet contains 50 mg carbidopa and 200 mg levodopa; trade name: Sinemet®) certified by MSD Pharma (Singapore) Pte. Ltd. under fasting and postprandial conditions.
100 Clinical Results associated with Hainan Huitong Biomedical Technology Co., Ltd
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