Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
12
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 3 Dec 2024 → 29 Apr 2025
- Decision date (initial)
- 2024-11-01
- 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
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Diagnostic Center, Clinical Pharmacology unit, Biomedicum
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- HUS Diagnostic Center, Clinical Pharmacology unit, Biomedicum
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 12 | 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 |
|---|---|---|---|---|---|
| Finland | 2024-12-03 | 2025-04-29 | 2024-12-03 | 2025-03-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-02 | Finland | Acceptable 2024-10-21
|
2024-11-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-06 | Finland | Acceptable 2024-10-21
|
2024-11-06 |