Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
30
Countries
1
Sites
1
bioequivalence and patch adhesion trial; therapeutical indication not studied
Key facts
- Sponsor
- LTS LOHMANN Therapie-Systeme AG
- 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
- 30 Sep 2024 → 15 Nov 2024
- Decision date (initial)
- 2023-05-22
- 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
bioequivalence and patch adhesion trial; therapeutical indication not studied
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10057852 | Nicotine dependence | 100000004873 |
| 20.0 | LLT | 10008374 | Cessation of smoking | 10041244 |
| 20.0 | PT | 10053325 | Smoking cessation therapy | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
LTS LOHMANN Therapie-Systeme AG
- Sponsor organisation
- LTS LOHMANN Therapie-Systeme AG
- Address
- Lohmannstrasse 2
- City
- Andernach
- Postcode
- 56626
- Country
- Germany
Scientific contact point
- Organisation
- LTS LOHMANN Therapie-Systeme AG
- Contact name
- Corporate Vice President, Head of Pharmaceutical Development II R&D
Public contact point
- Organisation
- LTS LOHMANN Therapie-Systeme AG
- Contact name
- Corporate Vice President, Head of Pharmaceutical Development II R&D
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 30 | 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 | 2024-09-30 | 2024-11-15 | 2024-10-01 | 2024-10-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-28 | Germany | Acceptable 2023-05-19
|
2023-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-19 | Germany | Acceptable 2024-08-23
|
2024-08-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-26 | Germany | Acceptable 2024-08-23
|
2024-09-26 |