Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1 g | Intravenous |
| Subject | clavulanic acid | Small molecule | 125 mg | Intravenous |
| Subject | clavulanic acid | Small molecule | 200 mg | Intravenous |