Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
64
Countries
1
Sites
1
Intended indication: Major Depressive Disorders with and without anxiety
Key facts
- Sponsor
- Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 31 May 2024 → 7 Aug 2024
- Decision date (initial)
- 2024-05-22
- 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
Intended indication: Major Depressive Disorders with and without anxiety
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012378 | Depression | 100000004873 |
| 21.1 | PT | 10057840 | Major depression | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.
- Sponsor organisation
- Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.
- Address
- Viale Amelia 70
- City
- Rome
- Postcode
- 00181
- Country
- Italy
Scientific contact point
- Organisation
- Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.
- Contact name
- Global Medical Dpt.
Public contact point
- Organisation
- Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.
- Contact name
- Global Medical Dpt.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 64 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-05-31 | 2024-08-07 | 2024-05-31 | 2024-06-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-22 | Germany | Acceptable 2024-04-04
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-28 | Germany | Acceptable 2024-06-10
|
2024-06-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-11 | Germany | Acceptable | 2024-07-17 |