Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
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]
- Trial duration
- 30 May 2025 → 14 Oct 2025
- Decision date (initial)
- 2025-02-21
- 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
- Lindenallee 70, Dahlwitz-Hoppegarten Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- Lavipharm S.A.
- Contact name
- Ligia Panaitescu
Public contact point
- Organisation
- Lavipharm S.A.
- Contact name
- Ligia Panaitescu
Lavipharm S.A.
- Sponsor organisation
- Lavipharm S.A.
- Address
- Agias Marinas Street, P. O. Box 59 P. O. Box 59
- City
- Peania
- Postcode
- 190 02
- Country
- Greece
Scientific contact point
- Organisation
- Lavipharm S.A.
- Contact name
- Ligia Panaitescu
Public contact point
- Organisation
- Lavipharm S.A.
- Contact name
- Ligia Panaitescu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 36 | 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 | 2025-05-30 | 2025-10-14 | 2025-05-30 | 2025-09-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Bulgaria | Acceptable 2025-02-17
|
2025-02-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-04 | Bulgaria | Acceptable | 2025-05-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-23 | Bulgaria | 2025-05-23 |