Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Not authorised
Participants planned
50
Countries
1
Sites
1
Not applicable. The study will be conducted on healthy volunteers.
Key facts
- Sponsor
- Ratiopharm GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2023-10-16
- 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
Not applicable. The study will be conducted on healthy volunteers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ratiopharm GmbH
- Sponsor organisation
- Ratiopharm GmbH
- Address
- Graf-Arco-Strasse 3, Donautal Donautal
- City
- Ulm
- Postcode
- 89079
- Country
- Germany
Scientific contact point
- Organisation
- Ratiopharm GmbH
- Contact name
- Constanze Scheel
Public contact point
- Organisation
- Ratiopharm GmbH
- Contact name
- Constanze Scheel
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Not authorised | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
3s Pharmacological Consultation & Res. S.R.L.
Clinical Research Department, Str Centru Dn2 92 3, 727046, Cumparatura
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-03 | Romania | Not acceptable 2023-10-16
|
2023-10-16 |