Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
16
Countries
1
Sites
1
Bioavailability Study under Fasting Conditions
Key facts
- Sponsor
- MIDAS Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2026-05-26
- 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
Bioavailability Study under Fasting Conditions
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039897 | Sedation | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MIDAS Pharma GmbH
- Sponsor organisation
- MIDAS Pharma GmbH
- Address
- Rheinstrasse 49, West West
- City
- Ingelheim Am Rhein
- Postcode
- 55218
- Country
- Germany
Scientific contact point
- Organisation
- MIDAS Pharma GmbH
- Contact name
- Anja Froese
Public contact point
- Organisation
- MIDAS Pharma GmbH
- Contact name
- Anja Froese
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-01 | Czechia | Acceptable 2026-05-26
|
2026-05-26 |