Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
75
Countries
1
Sites
1
In this study will be no subjects involved with any specific medical condition or disease
Key facts
- Sponsor
- Berlin-Chemie AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 25 Oct 2023 → 2 Apr 2024
- Decision date (initial)
- 2023-08-24
- 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
In this study will be no subjects involved with any specific medical condition or disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Berlin-Chemie AG
- Sponsor organisation
- Berlin-Chemie AG
- Address
- Glienicker Weg 125, Adlershof Adlershof
- City
- Berlin
- Postcode
- 12489
- Country
- Germany
Scientific contact point
- Organisation
- Berlin-Chemie AG
- Contact name
- Anja Pagenkopf
Public contact point
- Organisation
- Berlin-Chemie AG
- Contact name
- Anja Pagenkopf
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Lithuania | Ended | 75 | 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 |
|---|---|---|---|---|---|
| Lithuania | 2023-10-25 | 2024-04-02 | 2023-11-06 | 2024-03-05 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-06 | Lithuania | Acceptable 2023-08-23
|
2023-08-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-06 | Lithuania | Acceptable 2023-10-11
|
2023-10-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-08 | Lithuania | Acceptable 2024-01-30
|
2024-02-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-28 | Lithuania | Acceptable 2024-01-30
|
2024-03-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-04-16 | Lithuania | Acceptable 2024-01-30
|
2024-04-16 |