Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
170
Countries
1
Sites
1
Schizophrenia
Key facts
- Sponsor
- Geneora Pharma (Shijiazhuang) Co. Ltd., Geneora Pharma (Shijiazhuang) Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 23 Feb 2023 → 12 Feb 2024
- Decision date (initial)
- 2023-02-20
- 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
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Geneora Pharma (Shijiazhuang) Co. Ltd.
- Sponsor organisation
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Address
- Runjiang Headquarters International Building 5th Floor, No. 455 Yuhua East Rd, High-Tech Zone No. 455 Yuhua East Rd High-Tech Zone
- City
- Shijiazhuang
- Postcode
- 050031
- Country
- China
Scientific contact point
- Organisation
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Contact name
- Maggie Wang
Public contact point
- Organisation
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Contact name
- Maggie Wang
Geneora Pharma (Shijiazhuang) Co. Ltd.
- Sponsor organisation
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Address
- Runjiang Headquarters International Building 5th Floor, No 455 Yuhua East Rd, High Tech Zone No 455 Yuhua East Rd High Tech Zone
- City
- Shijiazhuang
- Postcode
- 050031
- Country
- China
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 170 | 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 |
|---|---|---|---|---|---|
| Portugal | 2023-02-23 | 2024-02-12 | 2023-02-23 | 2023-09-10 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-27 | Portugal | Acceptable 2023-01-25
|
2023-02-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-02-20 | Portugal | Acceptable 2023-01-25
|
2023-02-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-02-28 | Portugal | Acceptable 2023-01-25
|
2024-02-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-28 | Portugal | Acceptable 2023-01-25
|
2024-02-28 |