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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03054220
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women
* Age 18-60 years
* Body Mass Index 18-27
* Understanding of French language and able to give a written inform consent
* CYP2D6 genotype : combination of two fully-functional (normal activity) alleles or of one fully-functional and one non-functional allele (null activity), according to table 1, without gene multiplication
Exclusion Criteria:
* Pregnant or breastfeeding woman
* Any pathologies, use of drugs or food that may affect CYP2D6 activity
* Regular smokers of \>5 cigarettes/day
* Renal or hepatic impairment
* Medical history of chronic alcoholism or abuse of psychoactive drugs, including opiate addiction
* Liver transplantation
* Sensitivity to any of the drugs used
* Alteration of hepatic tests more than 2x normal
* Glomerular filtration rate \< 60 ml/min/1.73m2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03054220
Study Brief:
Protocol Section:
NCT03054220