Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
No therapeutic indication in the current trial with healthy volunteers.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Hermes Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 15 Nov 2024 → 11 Dec 2024
- Decision date (initial)
- 2024-11-11
- 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
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
Hermes Pharma GmbH
- Sponsor organisation
- Hermes Pharma GmbH
- Address
- Georg-Kalb-Strasse 5, Grosshesselohe, Großhesselohe Grosshesselohe Großhesselohe
- City
- Pullach I. Isartal
- Postcode
- 82049
- Country
- Germany
Scientific contact point
- Organisation
- Hermes Pharma GmbH
- Contact name
- Manager Medical Science & Regulatory Service
Public contact point
- Organisation
- Hermes Pharma GmbH
- Contact name
- Manager Medical Science & Regulatory Service
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 36 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-11-15 | 2024-12-11 | 2024-11-15 | 2024-11-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Bulgaria | Acceptable 2024-10-01
|
2024-11-11 |