Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
25
Countries
1
Sites
1
healthy subjects
Key facts
- Sponsor
- Parc De Salut Mar
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 27 Apr 2023 → 20 Oct 2023
- Decision date (initial)
- 2023-04-17
- 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 subjects
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10076471 | Drug doping | 10022117 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Parc De Salut Mar
- Sponsor organisation
- Parc De Salut Mar
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Parc De Salut Mar
- Contact name
- Rafael de la Torre
Public contact point
- Organisation
- Parc De Salut Mar
- Contact name
- Ana M Aldea Perona
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 25 | 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 |
|---|---|---|---|---|---|
| Spain | 2023-04-27 | 2023-10-20 | 2023-05-09 | 2023-10-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-13 | Spain | Acceptable 2023-04-17
|
2023-04-17 |