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Evaluation of the bioequivalence of two products containing esomeprazole under fed conditions: Esomeprazole-Syrup 40 mg dose (Test) vs. Nexium 40 mg (Comparator). An open, randomized, single dose, four-period, replicate, crossover trial in healthy volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512674-97-00
Acronym
CBP23003
Enrollment
54
Registered
2025-03-10
Start date
2025-03-11
Completion date
2025-05-19
Last updated
2025-03-10

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

Conditions

No therapeutic indication in the current trial with healthy volunteers.

Interventions

None listed

Sponsors

CCDRD Cooperative Clinical Drug Research and Development AG, BePharBel Manufacturing
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Bulgaria

Outcome results

None listed

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