Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
28
Countries
1
Sites
1
healthy subjects
Key facts
- Sponsor
- Antibiotice S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 26 May 2024 → 17 Jun 2024
- Decision date (initial)
- 2024-05-23
- 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 subjects
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antibiotice S.A.
- Sponsor organisation
- Antibiotice S.A.
- Address
- Str Valea Lupului Nr 1
- City
- Iasi
- Postcode
- 707410
- Country
- Romania
Scientific contact point
- Organisation
- Antibiotice S.A.
- Contact name
- Diana Iacob
Public contact point
- Organisation
- Antibiotice S.A.
- Contact name
- Diana Iacob
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ended | 28 | 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 |
|---|---|---|---|---|---|
| Romania | 2024-05-26 | 2024-06-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Romania | No conclusion 2024-05-20
|
2024-05-23 |