Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
28
Countries
1
Sites
1
bioavailability trial with healthy participants, therapeutic indication not studied
Key facts
- Sponsor
- Farco-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], Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 1 Jun 2026 → ongoing
- Decision date (initial)
- 2026-05-05
- 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 trial with healthy participants, therapeutic indication not studied
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10024758 | Local anaesthesia | 100000004865 |
| 21.1 | PT | 10062224 | Urethral operation | 100000004865 |
| 21.1 | PT | 10005028 | Bladder catheterisation | 100000004865 |
| 21.0 | PT | 10011814 | Cystoscopy | 100000004848 |
| 28.0 | PT | 10036786 | Proctoscopy | 100000004848 |
| 20.0 | PT | 10011781 | Cystitis | 100000004862 |
| 20.1 | PT | 10045434 | Ultrasound scan | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Farco-Pharma GmbH
- Sponsor organisation
- Farco-Pharma GmbH
- Address
- Gereonsmuehlengasse 1-11, Altstadt-Nord Altstadt-Nord
- City
- Cologne
- Postcode
- 50670
- Country
- Germany
Scientific contact point
- Organisation
- Farco-Pharma GmbH
- Contact name
- Dr. Jennifer Vollmer
Public contact point
- Organisation
- Farco-Pharma GmbH
- Contact name
- Dr. Jennifer Vollmer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 28 | 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 |
|---|---|---|---|---|---|
| Germany | 2026-06-01 | 2026-06-01 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-27 | Germany | Acceptable 2026-05-04
|
2026-05-05 |