Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
1
Not applicable (submitted trial is a BE study in healthy participants)
Key facts
- Sponsor
- Vipharm S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-07-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable (submitted trial is a BE study in healthy participants)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
| 20.0 | PT | 10007558 | Cardiac failure chronic | 100000004849 |
| 29.0 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vipharm S.A.
- Sponsor organisation
- Vipharm S.A.
- Address
- Ul. Artura I Franciszka Radziwillow 9
- City
- Ozarow Mazowiecki
- Postcode
- 05-850
- Country
- Poland
Scientific contact point
- Organisation
- Vipharm S.A.
- Contact name
- Vipharm Contact Point
Public contact point
- Organisation
- Vipharm S.A.
- Contact name
- Vipharm Contact Point
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-06-16 | Czechia | Acceptable 2026-06-30
|
2026-07-02 |