Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
64
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Laboratorios Leon Farma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 29 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-10
- 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
No medical condition.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Leon Farma S.A.
- Sponsor organisation
- Laboratorios Leon Farma S.A.
- Address
- Calle La Vallina S/N, Poligono Industrial Navatejera Poligono Industrial Navatejera
- City
- Villaquilambre
- Postcode
- 24193
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Leon Farma S.A.
- Contact name
- Amparo Amilburu
Public contact point
- Organisation
- Laboratorios Leon Farma S.A.
- Contact name
- Amparo Amilburu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ongoing, recruiting | 64 | 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 |
|---|---|---|---|---|---|
| Portugal | 2025-12-29 | 2025-12-29 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Portugal | Acceptable with conditions 2025-11-07
|
2025-11-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-02 | Portugal | Acceptable with conditions 2025-11-07
|
2026-01-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-21 | Portugal | Acceptable with conditions 2025-11-07
|
2026-01-21 |