Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
56
Countries
1
Sites
1
Study performed on healthy volunteers
Key facts
- Sponsor
- Ferrer Internacional S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Oct 2023 → 2 Feb 2024
- Decision date (initial)
- 2023-10-20
- 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
Study performed on healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ferrer Internacional S.A.
- Sponsor organisation
- Ferrer Internacional S.A.
- Address
- Avinguda Diagonal 549
- City
- Barcelona
- Postcode
- 08029
- Country
- Spain
Scientific contact point
- Organisation
- Ferrer Internacional S.A.
- Contact name
- Gemma Torres Sotodosos
Public contact point
- Organisation
- Ferrer Internacional S.A.
- Contact name
- Gemma Torres Sotodosos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
3s Pharmacological Consultation & Res. S.R.L.
Clinical Research Department, Str Centru Dn2 92 3, 727046, Cumparatura
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 |
|---|---|---|---|---|---|
| Romania | 2023-10-24 | 2024-02-02 | 2023-10-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-04 | Romania | Acceptable 2023-10-16
|
2023-10-20 |