A Single Dose, Fast State, Bioequivalence Study of CEFIXIMA ATB 400 mg Hard Capsules (Antibiotice S.A.) vs. CEFIXORAL® 400 mg Film Coated Tablets (A. Menarini Industrie Farmaceutiche Riunite s.r.l.)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504011-33-00

Acronym

CEFIAIS 01/2022

Enrollment

Registered

2023-05-17

Start date

2023-06-12

Completion date

2023-07-02

Last updated

2023-05-17

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

Conditions

healthy subjects

Brief summary

Pharmacokinetics • Cmax, AUClast, AUCtotal

Detailed description

a. pharmacokinetics • Tmax, thalf, kel and Residual area., Safety endpoints include, but are not limited to, adverse events (AEs), (including serious adverse events [SAEs], severe AEs, and AEs leading to discontinuation of the study drug), and clinically significant changes from baseline in vital sign measurements, and clinical laboratory test results

Interventions

DRUGCEFIXORAL 400 mg compresse rivestite

DRUGCefixima Atb 400mg

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics • Cmax, AUClast, AUCtotal	—

Secondary

Measure	Time frame
a. pharmacokinetics • Tmax, thalf, kel and Residual area., Safety endpoints include, but are not limited to, adverse events (AEs), (including serious adverse events [SAEs], severe AEs, and AEs leading to discontinuation of the study drug), and clinically significant changes from baseline in vital sign measurements, and clinical laboratory test results	—

Countries

Romania

Outcome results

None listed

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