Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
40
Countries
1
Sites
2
No therapeutic indication in the current trial with healthy volunteers.
Key facts
- Sponsor
- PharOS Pharmaceutical Oriented Servises Ltd., CCDRD Cooperative Clinical Drug Research and Development AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 7 May 2026
- Decision date (initial)
- 2025-10-08
- 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
No therapeutic indication in the current trial with healthy volunteers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
PharOS Pharmaceutical Oriented Servises Ltd.
- Sponsor organisation
- PharOS Pharmaceutical Oriented Servises Ltd.
- Address
- Lesvou Street End, Thesi Loggos Industrial Zone Thesi Loggos Industrial Zone
- City
- Metamorfossi
- Postcode
- 144 52
- Country
- Greece
Scientific contact point
- Organisation
- PharOS Pharmaceutical Oriented Servises Ltd.
- Contact name
- Project Manager
Public contact point
- Organisation
- PharOS Pharmaceutical Oriented Servises Ltd.
- Contact name
- Project Manager
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Project Manager
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Clinic of Clinical Pharmacology and Therapeutics UMHAT 'Tsaritsa Ioanna-ISUL' EAD
Clinic of Clinical Pharmacology and Therapeutics, 8 'Bialo more' Str., 1527, Sofia
Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
Diagnostic & Consultative Centre 'Ascendent' Ltd., 47 'Bacho Kiro' str., 1202, Sofia
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Bulgaria | Acceptable 2025-10-06
|
2025-10-08 |