Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
Comparative bioequivalence study in healthy volunteers under fasting conditions.
Key facts
- Sponsor
- MEDITOP Gyogyszeripari Kft.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 3 Nov 2025 → 25 Nov 2025
- Decision date (initial)
- 2025-09-10
- 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
Comparative bioequivalence study in healthy volunteers under fasting conditions.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10014522 | Embolism venous | 100000004866 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MEDITOP Gyogyszeripari Kft.
- Sponsor organisation
- MEDITOP Gyogyszeripari Kft.
- Address
- Ady Endre Utca 1
- City
- Pilisborosjeno
- Postcode
- 2097
- Country
- Hungary
Scientific contact point
- Organisation
- MEDITOP Gyogyszeripari Kft.
- Contact name
- Dr. Mészáros Ágota
Public contact point
- Organisation
- MEDITOP Gyogyszeripari Kft.
- Contact name
- Dr. Papp Zsuzsanna
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 | 2025-11-03 | 2025-11-25 | 2025-11-03 | 2025-11-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-13 | Czechia | Acceptable 2025-09-09
|
2025-09-10 |