Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
40
Countries
1
Sites
2
No therapeutic indication in the current trial with healthy volunteers.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Invox Belgium
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- completed 26 Nov 2025
- Decision date (initial)
- 2024-10-07
- 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
No therapeutic indication in the current trial with healthy volunteers.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10010952 | COPD | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Lindenallee 70, Dahlwitz-Hoppegarten Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- Invox Belgium
- Contact name
- Head of Regulatory
Public contact point
- Organisation
- Invox Belgium
- Contact name
- Head of Regulatory
Invox Belgium
- Sponsor organisation
- Invox Belgium
- Address
- Bioville Building Abis, Agoralaan Agoralaan
- City
- Diepenbeek
- Postcode
- 3590
- Country
- Belgium
Scientific contact point
- Organisation
- Invox Belgium
- Contact name
- Head of Regulatory
Public contact point
- Organisation
- Invox Belgium
- Contact name
- Head of Regulatory
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Bulgaria | Acceptable 2024-09-02
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-06 | Bulgaria | Acceptable 2024-12-04
|
2024-12-05 |