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Randomized, Open-label, Single-Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Amoxicilin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL to Augemntin ES 600 mg/42.9 mg/5 mL powder for oral suspension in Healthy Adult Male and Female Volunteers under Fed Conditions.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503233-22-00
Acronym
01-AMO-CLA-BIO-22
Enrollment
56
Registered
2023-08-24
Start date
2023-09-27
Completion date
2023-11-13
Last updated
2023-08-24

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

Conditions

Not applicable (submitted trial is a bioequivalence study in healthy subjects).

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