Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
26
Countries
1
Sites
2
adrenal insufficiency
Key facts
- Sponsor
- Universitaetsklinikum Heidelberg AöR
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 21 May 2025 → ongoing
- Decision date (initial)
- 2025-03-12
- 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
adrenal insufficiency
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Heidelberg AöR
- Sponsor organisation
- Universitaetsklinikum Heidelberg AöR
- Address
- Im Neuenheimer Feld 672, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Prof. Dr. med. Antje Blank
Public contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Prof. Dr. med. Antje Blank
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 26 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Endocrinology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Heidelberg AöR
KliPS, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 |
|---|---|---|---|---|---|
| Germany | 2025-05-21 | 2025-06-24 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Germany | Acceptable 2025-03-12
|
2025-03-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-31 | Germany | Acceptable 2025-04-09
|
2025-04-15 |