Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Intexo Societa Benefit S.r.l.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2024-09-19
- 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
Intexo Societa Benefit S.r.l.
- Sponsor organisation
- Intexo Societa Benefit S.r.l.
- Address
- Via Del Tritone 169
- City
- Rome
- Postcode
- 00187
- Country
- Italy
Scientific contact point
- Organisation
- Intexo Societa Benefit S.r.l.
- Contact name
- Regulatory Affairs Senior Manager
Public contact point
- Organisation
- Intexo Societa Benefit S.r.l.
- Contact name
- Regulatory Affairs Senior Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-11 | Portugal | Acceptable 2024-09-17
|
2024-09-19 |