Clinical trial • Phase III • Other
Silexan 80 mg for Healthy volunteers
Phase III trial of Silexan 80 mg for Healthy volunteers.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 05-09-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
Randomised, open-label, silexan 80 mg under fed vs fasted conditions in a two-period, two-sequence crossover design; no other drug comparator specified-controlled, crossover Phase III trial across 1 site in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Silexan 80 mg under fed vs fasted conditions in a two-period, two-sequence crossover design; no other drug comparator specified
- Crossover
- Yes
- Target Sample Size
- 24
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
France
- Earliest CTIS Part Ii Submission Date
- 06-12-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 3
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Biotrial
- Department Name
- Unité Clinique
- Contact Person Name
- Marina Klein
- Contact Person Email
- marina.klein@biotrial.com
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Dr. Willmar Schwabe GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Silexan 80 mg
- Modality
- Other
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg
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