Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
28
Countries
1
Sites
1
Antimigraine
Key facts
- Sponsor
- Qualix Pharma S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 10 Apr 2024 → 7 May 2024
- Decision date (initial)
- 2024-04-05
- 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
Antimigraine
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Qualix Pharma S.L.
- Sponsor organisation
- Qualix Pharma S.L.
- Address
- Carrer De La Botanica 137-139
- City
- L'Hospitalet De Llobregat
- Postcode
- 08908
- Country
- Spain
Scientific contact point
- Organisation
- Qualix Pharma S.L.
- Contact name
- Luis Climent
Public contact point
- Organisation
- Qualix Pharma S.L.
- Contact name
- Luis Climent
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 28 | 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 | 2024-04-10 | 2024-05-07 | 2024-04-11 | 2024-04-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Spain | Acceptable 2024-04-05
|
2024-04-05 |