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NOT YET RECRUITING
NCT07711262
PHASE3

Rupatifen Fumarate Capsules in Patients With Seasonal Allergic Rhinitis

Sponsor: Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Rupatifen Fumarate Capsules

Oral administration, one capsule once daily for 14 consecutive days

DRUG

Rupatadine Fumarate Tablets

Oral administration, one tablet once daily for 14 consecutive days

DRUG

Rupatifen Fumarate Capsules Placebo

Oral administration, one capsule once daily for 14 consecutive days

DRUG

Rupatadine Fumarate Tablets Placebo

Oral administration, one tablet once daily for 14 consecutive days

Locations (8)

Hebei General Hospital

Shijiazhuang, Hebei, China

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

Shandong Second Provincial General Hospital

Jinan, Shandong, China

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Emergency General Hospital

Beijing, China

Tianjin People's Hospital

Tianjin, China