Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
72
Countries
1
Sites
2
Nicotine use
Key facts
- Sponsor
- Swedish Match North Europe AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 17 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-17
- 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
Nicotine use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Swedish Match North Europe AB
- Sponsor organisation
- Swedish Match North Europe AB
- Address
- Sveavagen 44, Adolf Fredrik Adolf Fredrik
- City
- Stockholm
- Postcode
- 111 34
- Country
- Sweden
Scientific contact point
- Organisation
- Swedish Match North Europe AB
- Contact name
- Information contact point
Public contact point
- Organisation
- Swedish Match North Europe AB
- Contact name
- Information contact point
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 72 | 2 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2025-11-17 | 2025-11-17 | 2026-02-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Sweden | Acceptable 2025-11-17
|
2025-11-17 |