Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
102
Countries
1
Sites
1
corticosteroid-sensitive dermatosis
Key facts
- Sponsor
- Substipharm
- 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
- 12 Dec 2023 → 25 Jul 2024
- Decision date (initial)
- 2023-10-30
- 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
corticosteroid-sensitive dermatosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Substipharm
- Sponsor organisation
- Substipharm
- Address
- 24 Rue Erlanger
- City
- Paris
- Postcode
- 75016
- Country
- France
Scientific contact point
- Organisation
- Substipharm
- Contact name
- Florence TRESPEUCH
Public contact point
- Organisation
- Substipharm
- Contact name
- Florence TRESPEUCH
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 102 | 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 |
|---|---|---|---|---|---|
| France | 2023-12-12 | 2024-07-25 | 2023-12-12 | 2024-07-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | France | Acceptable 2023-10-23
|
2023-10-30 |