Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
42
Countries
1
Sites
1
Study performed on healthy volunteers.
Key facts
- Sponsor
- neuraxpharm Arzneimittel GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 31 Jan 2024 → 13 May 2024
- Decision date (initial)
- 2024-01-19
- 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
Study performed on healthy volunteers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
neuraxpharm Arzneimittel GmbH
- Sponsor organisation
- neuraxpharm Arzneimittel GmbH
- Address
- Elisabeth-Selbert-Strasse 23, Richrath Richrath
- City
- Langenfeld (rheinland)
- Postcode
- 40764
- Country
- Germany
Scientific contact point
- Organisation
- neuraxpharm Arzneimittel GmbH
- Contact name
- neuraxpharm Arzneimittel GmbH
Public contact point
- Organisation
- neuraxpharm Arzneimittel GmbH
- Contact name
- Neuraxpharm Pharmaceuticals S.L. Clinical Research Department, Barcelona
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
3s Pharmacological Consultation & Res. S.R.L.
Clinical Research Department, Comuna Bosanci, Calea Falticeni Nr 45, Cumparatura
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 |
|---|---|---|---|---|---|
| Romania | 2024-01-31 | 2024-05-13 | 2024-01-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-09 | Romania | Not acceptable 2023-11-27
|
2023-12-04 |