A randomized, single dose, cross-over, replicated, open-label bioequivalence study comparing indacaterol/glycopyrronium (85/43mcg inhalation powder hard capsules) (PG341 [Celon Pharma] vs Ultibro Breezhaler [Novartis])

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514725-38-00

Acronym

01INDA2024

Enrollment

Registered

2024-11-18

Start date

2025-05-26

Completion date

2025-09-01

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)

None listed

Sex/Gender

All

Age

18 Years to 64 Years

Poland

None listed

Source: EU CTIS · Data processed: Feb 4, 2026