Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
54
Countries
1
Sites
1
Healthy volunteers, therapeutic indication not studied
Key facts
- Sponsor
- Haleon CH SARL
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 5 Mar 2025 → 16 Jun 2025
- Decision date (initial)
- 2024-12-10
- 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
Healthy volunteers, therapeutic indication not studied
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10016283 | Febrile cold (excl flu like illness) | 10021881 |
| 20.0 | PT | 10028391 | Musculoskeletal pain | 100000004859 |
| 20.0 | LLT | 10031304 | Otalgia | 10013993 |
| 20.1 | LLT | 10034532 | Period pains | 10038604 |
| 27.0 | PT | 10068879 | Vaccination site pain | 100000004867 |
| 20.0 | LLT | 10016558 | Fever | 10018065 |
| 23.1 | LLT | 10049749 | Post procedural pain | 10022117 |
| 22.0 | PT | 10019211 | Headache | 100000004852 |
| 20.0 | LLT | 10027602 | Migraine headache | 10029205 |
| 21.1 | PT | 10040747 | Sinus pain | 100000004855 |
| 21.1 | LLT | 10028287 | Muscle ache | 10028395 |
| 20.0 | PT | 10044055 | Toothache | 100000004856 |
| 20.0 | PT | 10031161 | Osteoarthritis | 100000004859 |
| 20.1 | LLT | 10065602 | Fluctuating fever | 10018065 |
| 27.0 | LLT | 10088364 | Post vaccination fever | 100000004863 |
| 20.0 | LLT | 10014037 | Earache | 10013993 |
| 20.0 | LLT | 10003993 | Backache | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Haleon CH SARL
- Sponsor organisation
- Haleon CH SARL
- Address
- Case Postale 1279
- City
- Nyon 1
- Postcode
- 1260
- Country
- Switzerland
Scientific contact point
- Organisation
- Haleon CH SARL
- Contact name
- Haleon Contact Point Clinical trials
Public contact point
- Organisation
- Haleon CH SARL
- Contact name
- Haleon Contact Point Clinical trials
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 54 | 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 | 2025-03-05 | 2025-06-16 | 2025-03-05 | 2025-04-17 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | Germany | Acceptable 2024-11-29
|
2024-12-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-24 | Germany | Acceptable 2024-11-29
|
2025-02-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-04 | Germany | Acceptable 2024-11-29
|
2025-06-04 |