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Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the relative bioavailability of Test Product Naproxen sodium 660 mg modified release tablets to Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fasting conditions.s.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524035-39-00
Acronym
1062/25
Enrollment
32
Registered
2025-12-09
Start date
2026-01-14
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability study in healthy volunteers under fasting conditions.

Interventions

None listed

Sponsors

Laboratorios Cinfa S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026