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A Single Dose, Fasting state, Crossover Replicate Bioequivalence Study of Naproxen 500 mg/Esomeprazole 20 mg, modified-release tablets (Antibiotice S.A.) vs. Vimovo® 500 mg/20 mg film-coated tablets (Grunenthal Gmbh)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515662-14-00
Acronym
NAESAIS 02/2024
Enrollment
32
Registered
2024-10-31
Start date
2024-10-31
Completion date
2024-12-18
Last updated
2024-10-31

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

Conditions

healthy subjects

Interventions

None listed

Sponsors

Antibiotice S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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