Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
34
Countries
1
Sites
1
Not applicable (submitted trial is a bioequivalence in healthy subjects)
Key facts
- Sponsor
- Sciencepharma Sp. z o.o.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 1 Apr 2025 → 28 May 2025
- Decision date (initial)
- 2025-03-31
- 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 bioequivalence in healthy subjects)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10085331 | Lower urinary tract infection bacterial | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sciencepharma Sp. z o.o.
- Sponsor organisation
- Sciencepharma Sp. z o.o.
- Address
- Ul. Chelmska 30/34
- City
- Warsaw
- Postcode
- 00-725
- Country
- Poland
Scientific contact point
- Organisation
- Sciencepharma Sp. z o.o.
- Contact name
- Clinical Trials Team
Public contact point
- Organisation
- Sciencepharma Sp. z o.o.
- Contact name
- Clinical Trials Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 34 | 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 | 2025-04-01 | 2025-05-28 | 2025-04-14 | 2025-04-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-20 | Czechia | Acceptable 2025-03-25
|
2025-03-31 |