Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
100
Countries
1
Sites
1
Localized, therapy-resistant inflammatory skin diseases, for which the use of topical corticosteroids with very high potency is indicated.
Key facts
- Sponsor
- BELUPO lijekovi i kozmetika d.d.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 20 Nov 2023 → 12 Feb 2024
- Decision date (initial)
- 2023-09-11
- 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
Localized, therapy-resistant inflammatory skin diseases, for which the use of topical corticosteroids with very high potency is indicated.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10081154 | Skin lesion inflammation | 100000004858 |
| 21.0 | LLT | 10062249 | Skin inflammation | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BELUPO lijekovi i kozmetika d.d.
- Sponsor organisation
- BELUPO lijekovi i kozmetika d.d.
- Address
- Ulica Danica 5
- City
- Koprivnica
- Postcode
- 48000
- Country
- Croatia
Scientific contact point
- Organisation
- BELUPO lijekovi i kozmetika d.d.
- Contact name
- Tatjana Ajhler Duretek, MD, MSc
Public contact point
- Organisation
- BELUPO lijekovi i kozmetika d.d.
- Contact name
- Tatjana Ajhler Duretek, MD, MSc
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 100 | 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 |
|---|---|---|---|---|---|
| Poland | 2023-11-20 | 2024-02-12 | 2023-11-27 | 2024-02-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-18 | Poland | Acceptable with conditions 2023-09-04
|
2023-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-29 | Poland | Acceptable 2023-11-13
|
2023-11-15 |