Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
38
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Bluepharma Industria Farmaceutica S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 21 May 2024 → 17 Jun 2024
- Decision date (initial)
- 2024-05-14
- 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
Bluepharma Industria Farmaceutica S.A.
- Sponsor organisation
- Bluepharma Industria Farmaceutica S.A.
- Address
- Sao Martinho Do Bispo
- City
- Coimbra
- Postcode
- 3045-016
- Country
- Portugal
Scientific contact point
- Organisation
- Bluepharma Industria Farmaceutica S.A.
- Contact name
- Medical Affairs Department
Public contact point
- Organisation
- Bluepharma Industria Farmaceutica S.A.
- Contact name
- Medical Affairs Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 38 | 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 | 2024-05-21 | 2024-06-17 | 2024-05-21 | 2024-05-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-11 | Portugal | Acceptable 2024-05-08
|
2024-05-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | Portugal | Acceptable 2024-07-15
|
2024-07-15 |