Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Hemodynamic parameters is to be investigated -- comparing intravenous fluid therapy to oral fluid therapy
Key facts
- Sponsor
- Esbjerg Og Grindsted Sygehus
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Trial duration
- 18 Mar 2025 → 1 May 2025
- Decision date (initial)
- 2025-02-26
- 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
Hemodynamic parameters is to be investigated -- comparing intravenous fluid therapy to oral fluid therapy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Esbjerg Og Grindsted Sygehus
- Sponsor organisation
- Esbjerg Og Grindsted Sygehus
- Address
- Finsensgade 35
- City
- Esbjerg
- Postcode
- 6700
- Country
- Denmark
Scientific contact point
- Organisation
- Esbjerg Og Grindsted Sygehus
- Contact name
- Peter Biesenbach
Public contact point
- Organisation
- Esbjerg Og Grindsted Sygehus
- Contact name
- Peter Biesenbach
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 20 | 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 |
|---|---|---|---|---|---|
| Denmark | 2025-03-18 | 2025-05-01 | 2025-03-18 | 2025-04-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-25 | Denmark | Acceptable 2025-02-26
|
2025-02-26 |