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Completed Phase 1 Interventional

A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection

ClinicalTrials.gov ID: NCT05584683

Public ClinicalTrials.gov record NCT05584683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 1:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.

Study identification

NCT ID
NCT05584683
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Kaizen Bioscience Co.
Industry
Enrollment
39 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Months to 24 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 8, 2023
Primary completion
Dec 15, 2024
Completion
Dec 15, 2024
Last update posted
Feb 4, 2025

2023 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05584683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 4, 2025 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05584683 live on ClinicalTrials.gov.

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