drugset / Trial / NCT00354965

Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients

NCT00354965

Phase 1 Completed 52 enrolled GlaxoSmithKline
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.

Timeline

Start
2006-01-19
Primary completion
2007-04-02
Completion
2007-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 2000 mg Oral
Subject Clavulanate Unknown 125 mg Oral