Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
60
Countries
1
Sites
1
healthy volunteer
Key facts
- Sponsor
- Geiser Pharma S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 11 Mar 2024 → 15 Apr 2024
- Decision date (initial)
- 2023-12-04
- 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 volunteer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Geiser Pharma S.L.
- Sponsor organisation
- Geiser Pharma S.L.
- Address
- Labiano Bidea 45b, Mutilva Mutilva
- City
- Aranguren
- Postcode
- 31192
- Country
- Spain
Scientific contact point
- Organisation
- Geiser Pharma S.L.
- Contact name
- Francisco Abad Santos
Public contact point
- Organisation
- Geiser Pharma S.L.
- Contact name
- Ainara Lecumberri
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 60 | 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 |
|---|---|---|---|---|---|
| Spain | 2024-03-11 | 2024-04-15 | 2024-03-12 | 2024-04-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-08 | Spain | Acceptable with conditions 2023-12-04
|
2023-12-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-05 | Spain | Acceptable 2024-03-01
|
2024-03-01 |