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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date04 Feb 2013 |
比较丙酸倍氯米松/富马酸福莫特与布地奈德/富马酸福莫特罗治疗COPD的24周临床试验
[Translation] A 24-week clinical trial comparing beclomethasone dipropionate/formoterol fumarate with budesonide/formoterol fumarate in the treatment of COPD
主要目的:证明CHF1535pMDI治疗COPD患者在肺功能方面(第24周的早晨用药前一秒用力呼气量(FEV1)较基线变化)非劣效于信必可都保。 次要目的:评估CHF1535pMDI对其它肺功能参数和患者报告的结局(PRO)的影响。评估研究治疗的安全性和耐受性。
[Translation] Primary objective: To demonstrate the non-inferiority of CHF1535pMDI to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) before morning dosing at week 24) in patients with COPD. Secondary objectives: To assess the effect of CHF1535pMDI on other lung function parameters and patient-reported outcomes (PROs). To assess the safety and tolerability of the study treatment.
在健康中国受试者中评估 CHF 5993 吸入气雾剂100/6/12.5 μg 固定组方的药代动力学研究
[Translation] A pharmacokinetic study evaluating the 100/6/12.5 μg fixed-formulation CHF 5993 inhalation aerosol in healthy Chinese subjects
主要目标:在健康中国受试者中评价治疗剂量下单次和重复给予 CHF5993 pMDI 后和超治疗剂量下单次给予 CHF5993 pMDI 后,二丙酸倍氯米松 (BDP)、17 单丙酸倍氯米松 (B17MP)、福莫特罗和溴化吡铂 (GB) 的药代动力学。 次要目标:评估治疗剂量下第 1 天和第 7 天、以及超治疗剂量下第 1 天早晨给予 CHF 5993 pMDI 后 12 小时内的全身效应(收缩压 [SBP]、舒张压 [DBP]、心率 [HR]、QTcF)。评估研究治疗的安全性和耐受性。
[Translation] Primary Objectives: To evaluate the pharmacokinetics of beclomethasone dipropionate (BDP), beclomethasone-17 monopropionate (B17MP), formoterol, and picoplatin bromide (GB) after single and repeated administration of CHF5993 pMDI at therapeutic doses and after single administration of CHF5993 pMDI at supratherapeutic doses in healthy Chinese subjects. Secondary Objectives: To assess systemic effects (systolic blood pressure [SBP], diastolic blood pressure [DBP], heart rate [HR], QTcF) within 12 hours after morning administration of CHF 5993 pMDI on days 1 and 7 at therapeutic doses and on day 1 at supratherapeutic doses. To assess the safety and tolerability of study treatments.
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