Loading clinical trials...

Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Study to Determine PK Profiles of AUGMENTIN XR in Adolescents Weight at Least 40 kg Receiving Augmentin XR BID for 10 Days

NCT00354965•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient weighs at least 40 kg.
•Younger than 16 years old (no older than their 16th birthday).
•Suspected acute bacterial sinusitis.
•Able to swallow amoxicillin/clavulanate tablets.

Exclusion Criteria

•Personal or family history of adverse reactions or hypersensitivity or allergy to any penicillin or cephalosporin antibiotics.
•History of reaction to multiple allergens (if considered clinically relevant by the principal investigator).
•Patient is participating in another clinical trial or has received or anticipates receiving an investigational drug, vaccine, or medical device prior to the first dose of study medication or during the conduct of the study.
•History or presence of gastrointestinal, hepatic or renal disease or other conditions known to or that may interfere with the absorption, distribution, metabolism or excretion of study medication.
•Treatment with probenecid or allopurinol within 7 days of study entry.
•Female patients with a positive urine hCG (human chorionic gonadotropin) test at screening, or who are lactating (breast feeding) or are unwilling to be abstinent until completion of the follow-up visit.
•History of diarrhea due to Clostridium difficile following treatment with antibiotics.
•History of hypersensitivity or allergy to heparin or related preparations (if the clinical research unit uses heparin to maintain intravenous cannula patency).
•Patient is diagnosed with mononucleosis.
•Estimated Glomerular Filtration Rate (GFR) \<40 ml/min.

Locations (6)

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

North Dartmouth, Massachusetts, United States

GSK Investigational Site

Sylva, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Erie, Pennsylvania, United States

Key Dates

Start Date

January 19, 2006

Primary Completion Date

April 2, 2007

Completion Date

April 2, 2007

Last Updated

August 1, 2017

Enrollment

ACTUAL participants

Conditions

Infections, Respiratory Tract

Interventions

amoxicillin/clavulanate potassium

DRUG

A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution

NCT02688361

Infections, Respiratory Tract

View study

COMPLETEDPHASE1

Bioequivalence Study of Cephalexin Suspension 125

NCT01767532

Infections, Respiratory Tract

View study

COMPLETEDPHASE1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions