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

NCT05584683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-02-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Amoxicillin potassium clavulanate

LP-001 will be reconstituted and administered as a single dose

DRUG

Amoxicillin potassium clavulanate (Augmentin ES-600)

Augmentin ES-600 will be reconstituted and administered as a single dose

Sponsors & Collaborators

  • Kaizen Bioscience Co.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2024-12-16
Completion
2024-12-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584683 on ClinicalTrials.gov