Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
36
Countries
1
Sites
1
Not applicable (submitted trial is a bioavailability trial in healthy participants).
Key facts
- Sponsor
- Laboratorios Cinfa S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 22 Jun 2026 → ongoing
- Decision date (initial)
- 2026-06-04
- 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 bioavailability trial in healthy participants).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033371 | Pain | 100000004867 |
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
- Manuel Escolar Jurado
Public contact point
- Organisation
- Laboratorios Cinfa S.A.
- Contact name
- Manuel Escolar Jurado
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 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 | 2026-06-22 | 2026-06-22 |
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 2026-06-03
|
2026-06-04 |