Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
44
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
- 18 Mar 2024 → 25 Jun 2024
- Decision date (initial)
- 2023-05-29
- 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 | 44 | 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 | 2023-12-11 | 2024-06-25 | 2023-12-11 | 2024-04-08 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-10612
- Halt date
- 2023-12-15
- Member states concerned
- Portugal
- Publication date
- 2023-12-28
- Reason
- Sponsor decision
- Explanation
- Sponsor decided to review the protocol design due to new information concerning ISCV and ratio obtained in a fasting study with the same medicinal product.
- Follow-up measures
- No follow-up measures are foreseen since no subject received treatment (only recruitment occurred between the trial start and the temporary halt).
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-23 | Portugal | Acceptable 2023-05-23
|
2023-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-31 | Portugal | Acceptable 2024-02-27
|
2024-02-27 |