NCT02571959|CompletedPhase 1/2DMC
Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults
PHACO
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Sponsor study identifier
interventional
36
1 country
1
Study Start
July 24, 2015
Actual (reported)Primary Completion
October 13, 2015
Actual (reported)Study Completion
June 16, 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2015
Actual (reported)July 24, 2015
Actual (reported)October 8, 2015
Actual (reported)October 13, 2015
Actual (reported)June 16, 2017
Actual (reported)Systematic plasmatic clearance (Cl)
1 day
Area under the curve time - concentration (AUC 0-oo)
1 day
Half-life time (T1/2)
1 day
Volume of distribution (Vd)
1 day
Bioavailability after oral administration (F)
1 day
Constant of speed of absorption (Ka)
1 day
All volunteers receive a dose of amoxicillin and clavulanic acid
Day 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered
Day 2 : a dose of amoxicillin and clavulanic acid 1g / 125mg will be administered by oral route
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
amoxicillin and clavulanic acid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
amoxicillin and clavulanic acid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHopital Ambroise Pare
Boulogne, 92100, France
36 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2015
First Posted
October 8, 2015
Study Start
July 24, 2015
Actual (reported)Primary Completion
Effects of Intake of a Polysaccharides Mix on Metabolism, Hormones and Satiety in Obese Children.
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October 13, 2015
Actual (reported)Study Completion
June 16, 2017
Actual (reported)Last Updated
January 12, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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