drugset / Trial / NCT07711262

Rupatifen Fumarate Capsules in Patients With Seasonal Allergic Rhinitis

NCT07711262

Phase 3 Not yet recruiting 550 enrolled Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-07
Primary completion
2027-10
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rupatadine Small molecule Oral
Subject Rupatifen Unknown Oral