Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
12
Countries
1
Sites
1
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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
- 5 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-16
- 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
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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 Diagnostiikkakeskus, Kliinisen farmakologian yksikkö, Biomedicum
Public contact point
- Organisation
- HUS-yhtymae
- Contact name
- HUS Diagnostiikkakeskus, Kliinisen farmakologian yksikkö, Biomedicum
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruitment 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 | 2026-03-05 | 2026-03-10 | 2026-04-10 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-05 | Finland | Acceptable 2026-02-16
|
2026-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-23 | Finland | Acceptable 2026-02-16
|
2026-02-23 |