Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
24
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- Gebro Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- 22 Jan 2025 → 26 Feb 2025
- Decision date (initial)
- 2024-12-19
- 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
healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
| 20.0 | LLT | 10011402 | Crohn's disease (colon) | 10017947 |
| 27.0 | LLT | 10090623 | Generalized pustular psoriasis | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gebro Pharma GmbH
- Sponsor organisation
- Gebro Pharma GmbH
- Address
- Bahnhofbichl 13
- City
- Fieberbrunn
- Postcode
- 6391
- Country
- Austria
Scientific contact point
- Organisation
- Gebro Pharma GmbH
- Contact name
- clinical department
Public contact point
- Organisation
- Gebro Pharma GmbH
- Contact name
- clinical department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Czechia | 2025-01-22 | 2025-02-26 | 2025-01-22 | 2025-01-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | Czechia | Acceptable 2024-12-19
|
2024-12-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-10 | Czechia | Acceptable 2024-12-19
|
2025-01-10 |