Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
32
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Bial Portela & Ca S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 12 Aug 2024 → 17 Sep 2024
- Decision date (initial)
- 2024-07-11
- 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
Bial Portela & Ca S.A.
- Sponsor organisation
- Bial Portela & Ca S.A.
- Address
- A Avenida Da Siderurgia Nacional
- City
- Sao Mamede Do Coronado
- Postcode
- 4745-457
- Country
- Portugal
Scientific contact point
- Organisation
- Bial Portela & Ca S.A.
- Contact name
- Andreia Guimarães
Public contact point
- Organisation
- Bial Portela & Ca S.A.
- Contact name
- Andreia Guimarães
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | 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 |
|---|---|---|---|---|---|
| Portugal | 2024-08-12 | 2024-09-17 | 2024-08-12 | 2024-08-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Portugal | Acceptable 2024-07-06
|
2024-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-21 | Portugal | Acceptable 2024-09-16
|
2024-09-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-17 | Portugal | Acceptable 2024-09-16
|
2024-09-17 |