Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
42
Countries
1
Sites
1
Pharmacodynamic study under fasting condition.
Key facts
- Sponsor
- Adamed Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-06-02
- 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
Pharmacodynamic study under fasting condition.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10047065 | Vascular disorders | 12 |
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 | Authorised, recruitment pending | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Quinta-Analytica s.r.o.
Clinical Unit, Umelecka 305/1, Moravska Ostrava, Moravska Ostrava A Privoz
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-05-05 | Czechia | Acceptable 2026-06-01
|
2026-06-02 |