RecruitingPhase 3NCT07711262

Rupatifen Fumarate Capsules in Patients With Seasonal Allergic Rhinitis

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


Sponsor

Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.

Enrollment

550 participants

Start Date

Aug 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Rupatadine Fumarate Tablets, a drug called Rupatadine Fumarate Tablets Placebo, and others for people with seasonal allergic rhinitis. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRupatifen Fumarate Capsules

Oral administration, one capsule once daily for 14 consecutive days

DRUGRupatadine Fumarate Tablets

Oral administration, one tablet once daily for 14 consecutive days

DRUGRupatifen Fumarate Capsules Placebo

Oral administration, one capsule once daily for 14 consecutive days

DRUGRupatadine Fumarate Tablets Placebo

Oral administration, one tablet once daily for 14 consecutive days


Locations(18)

The No.2 Hospital of Baoding

Baoding, Hebei, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

Baogang Hospital of Inner Mongolia

Baotou, Inner Mongolia, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Linfen Central Hospital

Linfen, Shanxi, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Emergency General Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Tianjin People's Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07711262


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