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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01731067
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers aged from 18 to 60 years
* BMI between 18 and 25
* Understanding of French language and able to give a written inform consent.
Exclusion Criteria:
* Smoker
* Taking drugs which alter CYPs activity
* Renal or hepatic impairment
* Medical history of porphyria
* Medical history of chronic alcoholism or abuse of psychoactive drugs
* Liver transplantation
* Sensitivity to any of the drugs used
* Wearing contact lenses (risk of coloration with rifampicin)
* ECG showing long QT interval (\>0.46sec)
* Alteration of hepatic tests
* Presenting genetic polymorphism of poor CYP 2B6, 2C9, 2C19, 2D6 metabolisers
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01731067
Study Brief:
Protocol Section:
NCT01731067