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NCT00354965 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT00354965 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 52 participants.

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The verdict

NCT00354965, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study 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.

Interventions

  • DRUG amoxicillin/clavulanate potassium

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2006-01-19
Est. Completion 2007-04-02
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00354965

The ClinicalTrials.gov registry entry for NCT00354965 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which amoxicillin/clavulanate potassium is the first listed.

NCT00354965 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00354965 about?

NCT00354965 is a clinical study titled "Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients". 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 ou...

What is the current status of trial NCT00354965?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2006-01-19. Estimated completion is 2007-04-02.

What interventions are being tested in trial NCT00354965?

The interventions under investigation include: amoxicillin/clavulanate potassium (DRUG).

Who is sponsoring clinical trial NCT00354965?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.