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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508621-27-00
Acronym
NAESAIS 02/2023
Enrollment
32
Registered
2024-03-04
Start date
2024-03-05
Completion date
2024-04-30
Last updated
2024-03-04

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