Clinical trial • Phase II • Other
Naproxen sodium for Healthy volunteers
Phase II trial of Naproxen sodium for Healthy volunteers.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-04-2026
- First CTIS Authorization Date
- 24-04-2026
Trial design
Randomised, open-label, test product naproxen sodium 660 mg modified release tablets vs reference product actromadol 660 mg modified-release tablets (both 660 mg modified-release oral tablets as stated in title)-controlled, crossover Phase II trial across 1 site in Czechia.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test Product Naproxen sodium 660 mg modified release tablets vs Reference Product Actromadol 660 mg Modified-Release tablets (both 660 mg modified-release oral tablets as stated in title)
- Crossover
- Yes
- Target Sample Size
- 32
- Trial Duration For Participant
- 31
Eligibility
Recruits 32 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling available in the record.
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 1
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 32
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-03-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 46
- Number Of Sites
- 1
- Number Of Participants
- 32
Sites
- Site Name
- Quinta-Analytica s.r.o.
- Department Name
- Clinical Unit
- Contact Person Name
- Jiří Juchelka
- Contact Person Email
- jiri.juchelka@quinta.cz
Sponsor
Primary sponsor
- Full Name
- Laboratorios Cinfa S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Test Product Naproxen sodium 660 mg modified release tablets
- Active Substance
- Naproxen sodium
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 660 mg
- Dose Levels
- 660 mg
- Frequency
- multiple-dose
- Investigational Product Name
- Reference Product Actromadol 660 mg Modified-Release tablets
- Modality
- Small molecule
- Routes Of Administration
- oral
- Route
- oral
- Starting Dose
- 660 mg
- Dose Levels
- 660 mg
- Frequency
- multiple-dose
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