Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
Phase 1
Completed
- Conditions
- Infections, Respiratory Tract
- Interventions
- Registration Number
- NCT00354965
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARM 1 amoxicillin/clavulanate potassium -
- Primary Outcome Measures
Name Time Method Pharmacokinetic data on amoxicillin/clavulanate Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
- Secondary Outcome Measures
Name Time Method Safety, tolerability, and clinical response of oral amoxicillin/clavulanate twice daily for 10 days in adolescent patients.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Erie, Pennsylvania, United States