NCT02571959

Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults

Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population. The main evaluation criteria are PK parameters of amoxicillin / clavulanic: * Cl, systematic plasmatic clearance * Vd, volume of distribution * ASC 0-oo, area under the curve time - concentration * T1/2, half-life time * F, bioavailability after oral administration * Ka, constant of speed of absorption

Detailed description

Main objective Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Secondary objectives * Define dosage plans optimized with the antibiotic treatment to the obese subject * Ensure an adequacy of the treatment with the related infection * Formulate recommendations of dosage adaptations for a better individualization of treatments, by estimating several plans of doses by simulation to reach various PK/PD goals according to different theoretical MIC Methodology The pharmacokinetic analysis will be realized by approach of population allowing the estimation of the average parameters of amoxicillin and clavulanic acid as well as the interpersonal variability after an administration IV and an oral administration. Parameters's population and their variability will be estimated with the SAEM algorithm implemented in the software Monolix ( www.lixoft.eu ). For the main objective, PK parameters PK of amoxicillin and clavulanic acid will be determined to day 1 and day 2. They will be described by means of indicators of position (average and median) and of dispersal (standard deviations, quartiles). For secondary objectives, the profiles concentration/time of 1000 obese subjects will be determined by Monte Carlo method from PK parameters estimated at the balance by the model. For every feigned profile, the time during which the plasmatic concentration of amoxicillin and clavulanic acid is superior to a panel of theoretical MIC will be calculated by means of curves concentration - time determined for each of the subjects.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	amoxicillin and clavulanic acid	Day 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered
DRUG	amoxicillin and clavulanic acid	Day 2 : a dose of amoxicillin and clavulanic acid 1g / 125mg will be administered by oral route

Timeline

• Start date: 2015-07-24
• Primary completion: 2015-10-13
• Completion: 2017-06-16
• First posted: 2015-10-08
• Last updated: 2018-01-12

Locations

1 site across 1 country: France