Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
328
Countries
4
Sites
19
Schizophrenia
Key facts
- Sponsor
- Geneora Pharma (Shijiazhuang) Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2024-04-08
- 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
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
Locations
4 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 85 | 11 |
| Croatia | Authorised, recruitment pending | 29 | 3 |
| Italy | 0 | 1 | |
| Portugal | Authorised, recruitment pending | 56 | 4 |
| Rest of world
Bosnia and Herzegovina, Serbia, Georgia, Turkey, Moldova, Republic of
|
— | 158 | — |
Investigational sites
Center For Mental Health Vratsa EOOD
psychiatry, Belasita Str 1, 3000, Vratsa
Multiprofile Hospital For Active Treatment - Targovishte AD
psychiatry, West District, Syuren Blvd 1, Targovishte
Center For Skin And Venereal Diseases Veliko Tarnovo EOOD
psychiatry, Ulitsa Buzludzha 1, 5000, Veliko Tirnovo
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
psychiatry, Ulitsa Georgi Kochev 8-A, 5803, Pleven
"Multiprofile Hospital for Active Treatment Dr. Hristo Stambolski"
psychiatry, 16 "Starozagorska" Str.;, 6100, Kazanlak
State Psychiatric Hospital Tsarev Brod
psychiatry, Village, Hristo Botev St 30, Tsarev Brod
Diagnostics-Consultancy Center Mladost M Varna OOD
psychiatry, Bulevard Republika 15, 9020, Varna
Alexandrovska University Hospital
psychiatry, Georgy Sofiiski Str 1, 1431, Sofia
MBAL Dr. Ivan Seliminski - Sliven AD
psychiatry, Bulevard Hristo Botev 1, 8801, Sliven
Outpatient Clinic For Specialized Medical Care-Individual Practice For Specialized Medical Care-Psychiatry Dr. Georgi Hranov
psychiatry, Tzurnook Str 8, 1421, Sofia
Higya–DCC OOD
psychiatry, Ulitsa Sveti Ivan Rilski 3, 4400, Pazardzhik
KBC Split
psychiatry, Soltanska 1, 21000, Split
Klinika za psihijatriju Vrapce
psychiatry, Bolnicka Cesta 32, Zagreb, Grad Zagreb
Clinic for psychiatry Sveti Ivan
psychiatry, Jankomir 11, Zagreb, Grad Zagreb
Hospitais Senhor Do Bonfim S.A.
Neurosciences, Rua Da Mata 180, Vila Do Conde, Touguinho
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Psychiatry and Mental Health Service, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
CCAB Centro Clinico Academico Braga Associacao
Psychiatry Service, Lugar De Sete Fontes S Victor, 4710-243, Braga
Centro Hospitalar De Leiria E.P.E.
Psychiatry, Rua Das Olhalvas, 2410-197, Leiria
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Portugal | Acceptable 2024-04-01
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Acceptable | 2024-08-27 |