Clinical trial • Phase II • Other
Fentanyl for Healthy volunteers | Pain management
Phase II trial of Fentanyl for Healthy volunteers | Pain management. 30 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers | Pain management
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-12-2024
- First CTIS Authorization Date
- 03-04-2025
Trial design
Phase II trial across 1 site in Bulgaria.
- Target Sample Size
- 30
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 03-04-2025
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Multidisciplinary Hospital for Active Treatment (MHAT) Evropa OOD
- Department Name
- Department of gastroenterology
- Principal Investigator Name
- Ivo Bogdanov
- Principal Investigator Email
- ivoatbog@gmail.com
- Contact Person Name
- Ivo Bogdanov
- Contact Person Email
- ivoatbog@gmail.com
Sponsor
Primary sponsor
- Full Name
- CCDRD Cooperative Clinical Drug Research and Development AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Co-sponsors
- Lavipharm S.A.
Investigational products
- Investigational Product Name
- Bioequivalence of two transdermal therapeutic systems delivering 100 mcg/h fentanyl
- Active Substance
- Fentanyl
- Modality
- Small molecule
- Routes Of Administration
- Transdermal
- Route
- Transdermal
- Starting Dose
- 100 mcg/h
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