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Rupatifen Fumarate Capsules in Patients With Seasonal Allergic Rhinitis

NCT07711262 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

  • Seasonal Allergic Rhinitis

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

Sponsors & Collaborators

  • Fujian Mindong Rejuvenation Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711262 on ClinicalTrials.gov