Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
80
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 Jun 2023 → 24 Aug 2024
- Decision date (initial)
- 2023-06-07
- 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
- 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 | Ended | 80 | 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 | 2023-06-29 | 2024-08-24 | 2023-12-30 | 2024-02-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-30 | Portugal | Acceptable 2023-06-05
|
2023-06-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-21 | Portugal | Acceptable 2023-06-05
|
2024-02-21 |