Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Not authorised
Participants planned
74
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Helsinn Healthcare S.A., Helsinn Birex Pharmaceuticals Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2023-08-25
- 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
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Helsinn Healthcare S.A.
- Sponsor organisation
- Helsinn Healthcare S.A.
- Address
- Via Pian Scairolo 9
- City
- Pazzallo
- Postcode
- 6912
- Country
- Switzerland
Scientific contact point
- Organisation
- Helsinn Healthcare S.A.
- Contact name
- Silvia Parri
Public contact point
- Organisation
- Helsinn Healthcare S.A.
- Contact name
- Silvia Parri
Helsinn Birex Pharmaceuticals Limited
- Sponsor organisation
- Helsinn Birex Pharmaceuticals Limited
- Address
- Damastown Road, Damastown Industrial Park Damastown Industrial Park
- City
- Dublin 15
- Postcode
- D15 X925
- Country
- Ireland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Not authorised | 74 | 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 | 2023-06-22 | Germany | Not acceptable 2023-08-24
|
2023-08-25 |