Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
36
Countries
1
Sites
1
Not applicable (submitted trial is a bioavailability study in healthy subjects)
Key facts
- Sponsor
- Zaklady Farmaceutyczne Polpharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 21 Oct 2024 → 6 Dec 2024
- 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
Not applicable (submitted trial is a bioavailability study in healthy subjects)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10016770 | Flatulence bloating and distension | 10017947 |
| 20.0 | PT | 10016766 | Flatulence | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zaklady Farmaceutyczne Polpharma S.A.
- Sponsor organisation
- Zaklady Farmaceutyczne Polpharma S.A.
- Address
- Ul. Pelplinska 19
- City
- Starogard Gdanski
- Postcode
- 83-200
- Country
- Poland
Scientific contact point
- Organisation
- Zaklady Farmaceutyczne Polpharma S.A.
- Contact name
- Clinical R&D
Public contact point
- Organisation
- Zaklady Farmaceutyczne Polpharma S.A.
- Contact name
- Clinical R&D
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Quinta-Analytica s.r.o.
Clinic, Umelecka 305/1, Moravska Ostrava, Moravska Ostrava A Privoz
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 | 2024-10-21 | 2024-12-06 | 2024-10-21 | 2024-11-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Czechia | Acceptable 2024-09-13
|
2024-09-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-24 | Czechia | Acceptable 2024-09-13
|
2024-09-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-06 | Czechia | Acceptable 2024-09-13
|
2024-11-06 |