A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection
- Conditions
- PediatricBacterial Infections
- Interventions
- Drug: Amoxicillin potassium clavulanate (Augmentin ES-600)
- Registration Number
- NCT05584683
- Lead Sponsor
- Kaizen Bioscience Co.
- Brief 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.
- Detailed Description
This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LP-001 Arm Amoxicillin potassium clavulanate a novel amoxicillin/clavulanate formulation Augmentin ES-600 Amoxicillin potassium clavulanate (Augmentin ES-600) Augmentin ES-600
- Primary Outcome Measures
Name Time Method Mean plasma concentration-time curves of amoxicillin and clavulanic acid 6-8 hours post dose Calculation of mean plasma
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination 6-8 hours post dose Calculation of AUC
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination 6-8 hours post dose Calculation of CMAX
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States