Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
40
Countries
1
Sites
1
Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
Key facts
- Sponsor
- Celon Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 26 May 2025 → 1 Sep 2025
- Decision date (initial)
- 2024-11-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celon Pharma S.A.
- Sponsor organisation
- Celon Pharma S.A.
- Address
- Ul. Ogrodowa 2a, Kielpin Kielpin
- City
- Lomianki
- Postcode
- 05-092
- Country
- Poland
Scientific contact point
- Organisation
- Celon Pharma S.A.
- Contact name
- Clinical trial information point
Public contact point
- Organisation
- Celon Pharma S.A.
- Contact name
- Clinical trial information point
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-05-26 | 2025-09-01 | 2025-06-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Poland | Acceptable 2024-11-12
|
2024-11-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-15 | Poland | Acceptable 2024-11-12
|
2025-09-15 |