Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
54
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
- 6 Oct 2025 → 24 Nov 2025
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
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 | 54 | 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 | 2025-08-20 | 2025-11-24 | 2025-08-20 | 2025-11-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-97356
- Halt date
- 2025-09-02
- Member states concerned
- Portugal
- Publication date
- 2025-09-11
- Reason
- Study management related
- Explanation
- Lack of supply of IMP
- 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). Therefore, no consequences are expected from temporary halt in the evaluation of results and for the risk benefit assessment of the investigational medicinal product.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-26 | Portugal | Acceptable 2025-06-23
|
2025-07-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-18 | Portugal | Acceptable 2025-08-14
|
2025-08-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-18 | Portugal | Acceptable 2025-10-24
|
2025-10-24 |