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

NCT02571959 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-01-12

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571959 on ClinicalTrials.gov