Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
46
Countries
1
Sites
1
Bioequivalence study in healthy volunteers under fasting conditions
Key facts
- Sponsor
- Vipharm S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 15 Nov 2024 → 10 Jan 2025
- Decision date (initial)
- 2024-09-13
- 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
Bioequivalence study in healthy volunteers under fasting conditions
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 | Ended | 46 | 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 |
|---|---|---|---|---|---|
| Czechia | 2024-11-15 | 2025-01-10 | 2024-11-15 | 2024-11-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Czechia | Acceptable 2024-09-12
|
2024-09-13 |