drugset / Trial / NCT02571959

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

NCT02571959

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2015-07-24
Primary completion
2015-10-13
Completion
2017-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g Intravenous
Subject clavulanic acid Small molecule 125 mg Intravenous
Subject clavulanic acid Small molecule 200 mg Intravenous

Indications