Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
14
Countries
1
Sites
1
increased blood clotting
Key facts
- Sponsor
- Cepha s.r.o., Pozlab Sp. z o.o.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 28 Feb 2024 → 18 Mar 2024
- Decision date (initial)
- 2024-02-05
- 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
increased blood clotting
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10002383 | Angina pectoris | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cepha s.r.o.
- Sponsor organisation
- Cepha s.r.o.
- Address
- Komenskeho 19, Severni Predmesti Severni Predmesti
- City
- Plzen 1
- Postcode
- 323 00
- Country
- Czechia
Scientific contact point
- Organisation
- Pozlab Sp. z o.o.
- Contact name
- Malgorzata Gurynowicz
Public contact point
- Organisation
- Pozlab Sp. z o.o.
- Contact name
- Maria Łaciak
Pozlab Sp. z o.o.
- Sponsor organisation
- Pozlab Sp. z o.o.
- Address
- Ul. Parkowa 2
- City
- Poznan
- Postcode
- 60-775
- Country
- Poland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 14 | 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 | 2024-02-28 | 2024-03-18 | 2024-02-28 | 2024-03-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Czechia | Acceptable 2024-02-05
|
2024-02-05 |