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A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults Under Fasting Conditions

Infections, Bacterial Clinical Trial

Official title:
An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of SKF101804 Cefixime 400 mg Capsule Versus Cefixime 400 mg Capsule Reference Product in Healthy Adult Participants Under Fasting Conditions

Clinical Trial Summary

Cefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis. Cefixime acts by inhibiting the action of proteins involved in the synthesis of bacterial cell walls, which leads to bacterial cell lysis and cell death. Due to lack of bioequivalence between tablet/capsule and suspension formulation of cefixime, consideration needs to be given if the oral suspension is to be substituted for the tablet/capsule. This study is designed to assess whether test SKF101804 cefixime 400 milligrams (mg) capsule is bioequivalent to reference cefixime 400 mg capsule under fasting conditions in healthy adults. Subjects will be randomized in crossover manner to receive single oral doses of treatment A (SKF101804 cefixime test capsules) and treatment B (reference cefixime capsules), followed by a washout period of 7-14 days. Approximately 26 subjects will be included in the study and total duration in the study for each subject will be approximately 5 to 7 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03329547
Study type Interventional
Source GlaxoSmithKline
Contact
Status Withdrawn
Phase Phase 1
Start date January 11, 2018
Completion date February 2, 2018
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