Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
48
Countries
1
Sites
1
Not applicable (submitted trial is a bioavailability study in healthy subjects).
Key facts
- Sponsor
- Eva Pharma For Pharmaceuticals And Medical Appliances SAE
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 4 Nov 2024 → 6 Dec 2024
- Decision date (initial)
- 2024-09-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable (submitted trial is a bioavailability study in healthy subjects).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
| 21.1 | PT | 10058920 | Restless legs syndrome | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eva Pharma For Pharmaceuticals And Medical Appliances SAE
- Sponsor organisation
- Eva Pharma For Pharmaceuticals And Medical Appliances SAE
- Address
- Kafr El Gabal, 176 El Sadat Str 176 El Sadat Str
- City
- El Haram
- Postcode
- 12561
- Country
- Egypt
Scientific contact point
- Organisation
- Eva Pharma For Pharmaceuticals And Medical Appliances SAE
- Contact name
- Ramy Boles
Public contact point
- Organisation
- Eva Pharma For Pharmaceuticals And Medical Appliances SAE
- Contact name
- Ramy Boles
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 48 | 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 |
|---|---|---|---|---|---|
| Czechia | 2024-11-04 | 2024-12-06 | 2024-11-04 | 2024-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Czechia | Acceptable 2024-09-12
|
2024-09-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-04 | Czechia | Acceptable 2024-09-12
|
2024-10-04 |