Clinical trial • Phase II • Other
Lisdexamfetamine dimesylate for Healthy volunteers
Phase II trial of Lisdexamfetamine dimesylate for Healthy volunteers. 24 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 20-12-2024
Trial design
Phase II trial across 1 site in Portugal.
- Target Sample Size
- 24
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Portugal
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 20-12-2024
- Processing Time Days
- 99
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Marlene Fonseca
- Contact Person Email
- phase1@blueclinical.pt
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Pharmaplot P.C.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Greece
Investigational products
- Investigational Product Name
- Lisdexamfetamine dimesylate 10 mg Capsules
- Active Substance
- Lisdexamfetamine dimesylate
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
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