Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
Bioequivalence study under fasting conditions
Key facts
- Sponsor
- Adamed Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 15 Oct 2025 → 30 Jan 2026
- Decision date (initial)
- 2025-10-13
- 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
Bioequivalence study under fasting conditions
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adamed Pharma S.A.
- Sponsor organisation
- Adamed Pharma S.A.
- Address
- Ul. Mariana Adamkiewicza 6a, Pienkow Pienkow
- City
- Czosnow
- Postcode
- 05-152
- Country
- Poland
Scientific contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Pharmacokinetic Study Team
Public contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Pharmacokinetic Study Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 36 | 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 |
|---|---|---|---|---|---|
| Czechia | 2025-10-15 | 2026-01-30 | 2025-10-27 | 2025-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-09 | Czechia | Acceptable 2025-10-08
|
2025-10-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-03 | Czechia | Acceptable 2025-10-08
|
2025-12-03 |