Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
92
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 31 Aug 2023 → 24 Jan 2024
- Decision date (initial)
- 2023-08-02
- 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
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dr. Willmar Schwabe GmbH & Co. KG
- Sponsor organisation
- Dr. Willmar Schwabe GmbH & Co. KG
- Address
- Willmar-Schwabe-Strasse 4, Durlach Durlach
- City
- Karlsruhe
- Postcode
- 76227
- Country
- Germany
Scientific contact point
- Organisation
- Dr. Willmar Schwabe GmbH & Co. KG
- Contact name
- Susanne
Public contact point
- Organisation
- Dr. Willmar Schwabe GmbH & Co. KG
- Contact name
- Susanne
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 92 | 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 |
|---|---|---|---|---|---|
| France | 2023-08-31 | 2024-01-24 | 2023-09-06 | 2024-01-11 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-17 | France | Acceptable 2023-07-28
|
2023-08-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-27 | France | Acceptable 2023-07-28
|
2023-09-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-09 | France | Acceptable 2023-07-28
|
2023-11-09 |