Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
28
Countries
1
Sites
1
bioavailability trial with healthy volunteers, therapeutical indication not studied
Key facts
- Sponsor
- Teikoku Seiyaku Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 12 Feb 2025 → 14 Apr 2025
- Decision date (initial)
- 2024-12-18
- 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
bioavailability trial with healthy volunteers, therapeutical indication not studied
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10006502 | Bruise | 10022117 |
| 20.0 | LLT | 10028361 | Muscular pain | 10028395 |
| 20.0 | LLT | 10002549 | Ankle sprain | 10022117 |
| 20.0 | LLT | 10028338 | Muscle sprains | 10022117 |
| 20.0 | LLT | 10002550 | Ankle sprains and strains | 10022117 |
| 21.1 | LLT | 10028362 | Muscular pains | 10028395 |
| 20.0 | LLT | 10028337 | Muscle sprain | 10022117 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teikoku Seiyaku Co. Ltd.
- Sponsor organisation
- Teikoku Seiyaku Co. Ltd.
- Address
- 567 Sanbonmatsu
- City
- Higashikagawa
- Postcode
- 769-2695
- Country
- Japan
Scientific contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Public contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 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 | 2025-02-12 | 2025-04-14 | 2025-02-12 | 2025-02-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-18 | Germany | Acceptable 2024-11-29
|
2024-12-18 |