[Translation] Pharmacokinetics of Minodronic Acid Tablets in Single and Multiple Dosing Studies in Humans
研究中国健康志愿者单次、多次口服江苏笃诚医药科技股份有限公司生产的米诺膦酸片后人体内药代动力学特征,为临床用药提供依据。
[Translation] To study the pharmacokinetic characteristics of Chinese healthy volunteers after single or multiple oral administration of minodronic acid tablets produced by Jiangsu Ducheng Pharmaceutical Technology Co., Ltd., to provide evidence for clinical medication.
[Translation] Human Bioequivalence Test of Minodronate Tablets
主要研究目的:以アステラス製薬株式会社生产的米诺膦酸片(商品名:Bonoteo,规格:1mg/片)为参比制剂,以江苏笃诚医药科技股份有限公司研发的米诺膦酸片(规格:1mg/片)为受试制剂,评价两种制剂在中国健康受试者中空腹状态下的生物等效性。
次要研究目的:观察中国健康受试者口服受试制剂米诺膦酸片(规格:1mg/片)和参比制剂米诺膦酸片(商品名:Bonoteo,规格:1mg/片)的安全性。
[Translation] Main research purposes: Take minodronic acid tablets (trade name: Bonoteo, specification: 1 mg/tablet) produced by Asteras Co., Ltd. : 1mg/tablet) was the test preparation, and the bioequivalence of the two preparations in the fasting state of Chinese healthy subjects was evaluated.
Secondary research purpose: To observe the safety of the test preparation minodronic acid tablets (specification: 1mg/tablet) and the reference preparation minodronic acid tablets (trade name: Bonoteo, specification: 1mg/tablet) in Chinese healthy subjects sex.
以碳酸钙D3咀嚼片+维生素D滴剂为基础用药,评价米诺膦酸片治疗绝经后妇女骨质疏松的有效性和安全性的试验
[Translation] A trial to evaluate the efficacy and safety of minodronic acid tablets in the treatment of postmenopausal women with osteoporosis based on calcium carbonate D3 chewable tablets + vitamin D drops
以安慰剂对照,腰椎平均骨密度变化率为主要疗效指标,评价米诺膦酸片治疗绝经后妇女骨质疏松患者的有效性和安全性,为注册提供临床依据.
[Translation] Taking the placebo control, the average lumbar spine bone mineral density change rate as the main efficacy index, to evaluate the efficacy and safety of minodronic acid tablets in the treatment of postmenopausal women with osteoporosis, and to provide clinical basis for registration.
100 Clinical Results associated with Jiangsu Ducheng Pharmaceuticals Co., Ltd.
0 Patents (Medical) associated with Jiangsu Ducheng Pharmaceuticals Co., Ltd.
100 Deals associated with Jiangsu Ducheng Pharmaceuticals Co., Ltd.
100 Translational Medicine associated with Jiangsu Ducheng Pharmaceuticals Co., Ltd.