Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
32
Countries
1
Sites
1
not applicable (submitted trial is a bioequivalence study
Key facts
- Sponsor
- Laboratorios Cinfa S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Aug 2025 → 18 Sep 2025
- Decision date (initial)
- 2025-08-06
- 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
not applicable (submitted trial is a bioequivalence study
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10007554 | Cardiac failure | 100000004849 |
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
| 28.0 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Cinfa S.A.
- Sponsor organisation
- Laboratorios Cinfa S.A.
- Address
- Travesia De Roncesvalles 1, Olloki Olloki
- City
- Esteribar
- Postcode
- 31699
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Cinfa S.A.
- Contact name
- Rubén Rubén Estepa Sanz
Public contact point
- Organisation
- Laboratorios Cinfa S.A.
- Contact name
- Rubén Rubén Estepa Sanz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 32 | 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 | 2025-08-20 | 2025-09-18 | 2025-08-20 | 2025-09-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-26 | Czechia | Acceptable 2025-08-01
|
2025-08-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-29 | Czechia | Acceptable 2025-08-01
|
2025-08-29 |