Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
32
Countries
1
Sites
1
cold and flu
Key facts
- Sponsor
- Biofarm S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 19 Dec 2024 → 21 Feb 2025
- Decision date (initial)
- 2024-11-20
- 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
cold and flu
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10016793 | Flu syndrome | 10021881 |
| 22.1 | LLT | 10010106 | Common cold | 10021881 |
| 20.0 | PT | 10056350 | Pain management | 100000004865 |
| 20.1 | LLT | 10016797 | Flu-like symptoms | 10018065 |
| 20.0 | LLT | 10016558 | Fever | 10018065 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biofarm S.A.
- Sponsor organisation
- Biofarm S.A.
- Address
- Strada Logofatul Tautu 99
- City
- Bucharest
- Postcode
- 031212
- Country
- Romania
Scientific contact point
- Organisation
- Biofarm S.A.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Biofarm S.A.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | 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 |
|---|---|---|---|---|---|
| Greece | 2024-12-19 | 2025-02-21 | 2024-12-27 | 2025-01-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Greece | Acceptable 2024-10-11
|
2024-11-20 |