Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02571959
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Total Bilirubine \> 3 LSN
* Lipase \> 3 LSN
* Factor V \< 50 %
* Alcoholism chronicles (consumption superior to 30 g of alcohol a day, amount to 3 glasses of wine)
* Significant anomaly of the electrocardiogram, in particular QTc \> 450 msec
* Subject susceptible not to respect the modalities of the study
* Drug addiction intra venous
* Any medical conditions which according to the judgment(sentence) of the investigator would may interfere with the moderate pharmacokinetic parameters
* People placed under legal protection
* Histories of bariatric surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02571959
Study Brief:
Protocol Section:
NCT02571959