Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
50
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Alkaloid AD Skopje
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 17 Dec 2024
- Decision date (initial)
- 2023-10-27
- 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
No medical condition.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alkaloid AD Skopje
- Sponsor organisation
- Alkaloid AD Skopje
- Address
- Boulevard Aleksandar Makedonski 12
- City
- Skopje
- Postcode
- 1000
- Country
- North Macedonia
Scientific contact point
- Organisation
- Alkaloid AD Skopje
- Contact name
- Luís Almeida
Public contact point
- Organisation
- Alkaloid AD Skopje
- Contact name
- Luís Almeida
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-28 | Portugal | Acceptable 2023-10-09
|
2023-10-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-07 | Portugal | Acceptable 2023-10-09
|
2024-02-07 |