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A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on two amoxicillin-clavulanic acid film-coated tablet formulations in healthy volunteers under fed conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521718-24-00
Acronym
01-AMO-CLA-BIO-25
Enrollment
56
Registered
2025-07-15
Start date
2025-07-28
Completion date
2025-12-17
Last updated
2025-07-15

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

Conditions

infections

Interventions

None listed

Sponsors

Tarchominskie Zaklady Farmaceutyczne Polfa 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