Clinical trial • Phase II • Other
Cladribine for Healthy volunteers
Phase II trial of Cladribine for Healthy volunteers. Mavenclad® 10 mg tablets (Cladribine) single oral dose under fed conditions-controlled.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 08-10-2025
Trial design
Mavenclad® 10 mg tablets (Cladribine) single oral dose under fed conditions-controlled Phase II trial across 2 sites in Bulgaria.
- Comparator
- Mavenclad® 10 mg tablets (Cladribine) single oral dose under fed conditions
- Target Sample Size
- 40
Eligibility
Recruits 40 No vulnerable populations selected; only healthy adult subjects. isVulnerablePopulationSelected=false; consent expected from adult participants (no assent/parental consent described)..
- Vulnerable Population
- No vulnerable populations selected; only healthy adult subjects. isVulnerablePopulationSelected=false; consent expected from adult participants (no assent/parental consent described).
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 40
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 91
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- Clinic of Clinical Pharmacology and Therapeutics UMHAT 'Tsaritsa Ioanna-ISUL' EAD
- Department Name
- Clinic of Clinical Pharmacology and Therapeutics
- Contact Person Name
- Andrey Petrov
- Contact Person Email
- andrewpbg@yahoo.com
- Site Name
- Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
- Department Name
- Diagnostic & Consultative Centre 'Ascendent' Ltd.
- Contact Person Name
- Ivo Bogdanov
- Contact Person Email
- ivoatbog@gmail.com
Sponsor
Primary sponsor
- Full Name
- PharOS Pharmaceutical Oriented Servises Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Greece
Co-sponsors
- CCDRD Cooperative Clinical Drug Research and Development AG
Investigational products
- Investigational Product Name
- Cladribine 10 mg Tablets (test product)
- Active Substance
- Cladribine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg (single dose)
- Frequency
- single dose
- Maximum Dose
- 10 mg
- Investigational Product Name
- Mavenclad® 10 mg tablets (Cladribine) (reference product)
- Active Substance
- Cladribine
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg (single dose)
- Frequency
- single dose
- Maximum Dose
- 10 mg
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