Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults
Status:
Completed
Trial end date:
2017-06-16
Target enrollment:
Participant gender:
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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba