Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
NCT07198347 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-09-30
Summary
This is a Phase 3, randomized, double-blind, active-controlled clinical trial designed to evaluate the efficacy and safety of AG2001 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.
Conditions
- Acute Bronchitis
Interventions
- DRUG
-
AG2001
Oral administration, three times daily for 7 days.
- DRUG
-
AG20011
Oral administration, three times daily for 7 days.
- DRUG
-
AG20012
Oral administration, three times daily for 7 days.
Sponsors & Collaborators
-
Ahn-Gook Pharmaceuticals Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-01
- Primary Completion
- 2026-03-31
- Completion
- 2026-10-31
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