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Clinical Trials associated with Rupatifen fumarate / Not yet recruitingPhase 3 A Randomized, Double-blind, Positive-control and Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety in Rupatifen Fumarate Capsules for the Seasonal Allergic Rhinitis Patients
This Phase Ⅲ randomized, double-blind, active- and placebo-controlled trial aims to assess the efficacy and safety of Rupatifen Fumarate Capsules for seasonal allergic rhinitis. Eligible participants will be randomized to Rupatifen Fumarate Capsules, Rupatadine Fumarate Tablets (active comparator), or matching placebo. All treatments are administered once daily at a consistent time with a 24 ± 2-hour interval between doses for 2 consecutive weeks.
Start Date01 Jul 2026 |
Sponsor / Collaborator- |
/ Not yet recruitingPhase 3IIT A randomized, double-blind, positive-control and placebo-controlled phase Ⅲ clinical study to evaluate the efficacy and safety in Rupatifen Fumarate Capsules for the seasonal allergic rhinitis patients
评价富马酸卢帕替芬胶囊在季节性过敏性鼻炎受试者中的安全性和有效性的Ⅱ期临床研究
[Translation] Phase II clinical study to evaluate the safety and efficacy of rupatifene fumarate capsules in subjects with seasonal allergic rhinitis
主要目的:与对照药品相比,评价富马酸卢帕替芬胶囊治疗季节性过敏性鼻炎的有效性。
次要目的:(1)与对照药品相比,评价富马酸卢帕替芬胶囊改善季节性过敏性鼻炎的临床疗效。(2)评价富马酸卢帕替芬胶囊治疗季节性过敏性鼻炎的安全性。
药代动力学目的:评价富马酸卢帕替芬胶囊在季节性过敏性鼻炎患者中的群体药代动力学特征。
[Translation] Primary objective: To evaluate the efficacy of rupatifene fumarate capsules in the treatment of seasonal allergic rhinitis compared with control drugs.
Secondary objectives: (1) To evaluate the clinical efficacy of rupatifene fumarate capsules in improving seasonal allergic rhinitis compared with control drugs. (2) To evaluate the safety of rupatifene fumarate capsules in the treatment of seasonal allergic rhinitis.
Pharmacokinetic objective: To evaluate the population pharmacokinetic characteristics of rupatifene fumarate capsules in patients with seasonal allergic rhinitis.
100 Clinical Results associated with Rupatifen fumarate
100 Translational Medicine associated with Rupatifen fumarate
100 Patents (Medical) associated with Rupatifen fumarate
100 Deals associated with Rupatifen fumarate