Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
15
Countries
1
Sites
1
Edoxaban is used as antithrombotic agents, but it is a bioequivalence trial and the study population is healthy volunteers
Key facts
- Sponsor
- Biohorm S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2022-12-22
- 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
Edoxaban is used as antithrombotic agents, but it is a bioequivalence trial and the study population is healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biohorm S.L.
- Sponsor organisation
- Biohorm S.L.
- Address
- Avinguda Del Cami Reial 51-57
- City
- Palau-Solita I Plegamans
- Postcode
- 08184
- Country
- Spain
Scientific contact point
- Organisation
- Biohorm S.L.
- Contact name
- Iñaki Izquierdo Pulido
Public contact point
- Organisation
- Biohorm S.L.
- Contact name
- Daniel Peris González
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-05 | Spain | Acceptable 2022-12-20
|
2022-12-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-03 | Spain | Acceptable 2023-09-15
|
2023-09-15 |