Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
14
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Echo Pharmaceuticals B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 23 Feb 2024 → 4 Apr 2024
- Decision date (initial)
- 2024-02-19
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Echo Pharmaceuticals B.V.
- Sponsor organisation
- Echo Pharmaceuticals B.V.
- Address
- Robert Boyleweg 4
- City
- Leiden
- Postcode
- 2333 CG
- Country
- Netherlands
Scientific contact point
- Organisation
- Echo Pharmaceuticals B.V.
- Contact name
- Clinical Research Manager
Public contact point
- Organisation
- Echo Pharmaceuticals B.V.
- Contact name
- Clinical Research Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 14 | 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 |
|---|---|---|---|---|---|
| Hungary | 2024-02-23 | 2024-04-04 | 2024-02-26 | 2024-03-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-05 | Hungary | Acceptable 2024-02-19
|
2024-02-19 |