NCT02571959

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 24, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

April 14, 2015

Last Update Submit

January 11, 2018

Conditions

Obesity

Keywords

ObesityPharmacologyAmoxicillin-Potassium Clavulanate Combination

Outcome Measures

Primary Outcomes (1)

  • Systematic plasmatic clearance (Cl)

    1 day

Secondary Outcomes (5)

  • 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

Study Arms (1)

amoxicillin and clavulanic acid

EXPERIMENTAL

All volunteers receive a dose of amoxicillin and clavulanic acid

Drug: amoxicillin and clavulanic acid

Interventions

amoxicillin and clavulanic acidDRUG

Day 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered

Also known as: AMOXICILLINE / acide clavulonique SANDOZ
amoxicillin and clavulanic acid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary obese
  • Body mass index upper to 30 kg/m2
  • Age from 18 to 65 years
  • Signed free and lit consent
  • Possible participation according to the national file of the volunteers of the French Ministry of Health.
  • Volunteers affiliated to the Social Security

You may not qualify if:

  • Pregnancy
  • Evolutionary pregnancy or feeding
  • Allergy in ß-lactamines (nettle rash, oedema of Quincke)
  • Digestive intolerance with amoxicillin / clavulanic acid
  • Infection by the virus of the HIV ( positive Ac anti HIV)
  • Infection by the virus of the hepatitis B ( positive Ag Hbs)
  • Infection by the virus of the hepatitis C ( positive Ac anti VHC)
  • Hepatic cirrhosis at the Child-Pugh C stage(stadium)
  • Biological parameters:
  • Polynucléaires neutrophiles 750 / mm3
  • Haemoglobin 8g / dL
  • Patellets 60 000 / mm3
  • Creatinin clearance, according to MDRD, DFG 50 mL / min / 1,73m2
  • ASAT or ALAT \> 3 times the superior limit of the normal (LSN)
  • Phosphatase alkaline \> 3 LSN
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Ambroise Pare

Boulogne, 92100, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Amoxicillin-Potassium Clavulanate CombinationAmoxicillin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

October 8, 2015

Study Start

July 24, 2015

Primary Completion

October 13, 2015

Study Completion

June 16, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

FR(1)