Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
54
Countries
1
Sites
1
No therapeutic indication in the current trial with healthy volunteers.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, BePharBel Manufacturing
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Jun 2025 → 8 Oct 2025
- Decision date (initial)
- 2025-03-10
- 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.
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
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project manager
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project manager
BePharBel Manufacturing
- Sponsor organisation
- BePharBel Manufacturing
- Address
- Rue Du Luxembourg 13
- City
- Courcelles
- Postcode
- 6180
- Country
- Belgium
Scientific contact point
- Organisation
- BePharBel Manufacturing
- Contact name
- Olivier Laloux
Public contact point
- Organisation
- BePharBel Manufacturing
- Contact name
- Vincent Stéphenne
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 54 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-06-12 | 2025-10-08 | 2025-06-12 | 2025-09-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-20 | Bulgaria | Acceptable 2025-03-04
|
2025-03-10 |