Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 3 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-21
- 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
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Ruben Mijnster
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Ruben Mijnster
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, P. O. Box 2040, 3000 CA, Rotterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-03 | 2024-10-03 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-10 | Netherlands | Acceptable 2024-08-21
|
2024-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-19 | Netherlands | Acceptable 2024-10-03
|
2024-10-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-06 | Netherlands | Acceptable 2025-02-17
|
2025-02-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-19 | Netherlands | 2025-02-19 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-19 | Netherlands | Acceptable 2026-02-04
|
2026-02-04 |