Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the treatment of major depressive episodes in adults
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Biofarm Sp. z o.o.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Jun 2024 → 15 Aug 2024
- Decision date (initial)
- 2024-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
No therapeutic indication in the current trial with healthy volunteers. The intended indication is for the treatment of major depressive episodes in adults
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
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
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager - CRO
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager - CRO
Biofarm Sp. z o.o.
- Sponsor organisation
- Biofarm Sp. z o.o.
- Address
- Ul. Walbrzyska 13
- City
- Poznan
- Postcode
- 60-198
- Country
- Poland
Scientific contact point
- Organisation
- Biofarm Sp. z o.o.
- Contact name
- Ewa Puk, MSc, PhD
Public contact point
- Organisation
- Biofarm Sp. z o.o.
- Contact name
- Ewa Puk, MSc, PhD
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 | 2024-06-29 | 2024-08-15 | 2024-06-29 | 2024-07-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-04 | Bulgaria | Acceptable 2024-02-21
|
2024-04-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-05 | Bulgaria | Acceptable 2024-07-22
|
2024-07-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-29 | Bulgaria | 2024-07-29 |