Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
Bioequivalence trial in healthy volunteers
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Lavipharm S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Decision date (initial)
- 2025-04-03
- 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
Bioequivalence trial in healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10056350 | Pain management | 100000004865 |
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
- Lavipharm S.A.
- Contact name
- Lavipharm S.A. R&D Director: Panaitescu Ligia
Public contact point
- Organisation
- Lavipharm S.A.
- Contact name
- Lavipharm S.A. R&D Director: Panaitescu Ligia
Lavipharm S.A.
- Sponsor organisation
- Lavipharm S.A.
- Address
- Agias Marinas Street, P. O. Box 59 P. O. Box 59
- City
- Peania
- Postcode
- 19002
- Country
- Greece
Scientific contact point
- Organisation
- Lavipharm S.A.
- Contact name
- R&D Director: Ligia Panaitescu
Public contact point
- Organisation
- Lavipharm S.A.
- Contact name
- R&D Director: Ligia Panaitescu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 30 | 1 |
| 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 | 2024-12-19 | Bulgaria | Acceptable 2025-04-02
|
2025-04-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-15 | Bulgaria | Acceptable 2025-04-02
|
2025-04-15 |