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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01947920
Eligibility Criteria:
Inclusion Criteria:
* body mass index between 18 and 30 kg/m², inclusive
* body weight not less than 50 kg
* have a normal electroencephalogram under basic and stimulated conditions
* have a 12-lead ECG that is consistent with normal cardiac conduction and function
* have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration
Exclusion Criteria:
* any personal or family history of epileptic seizures or convulsions
* have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
* have suffered from loss of consciousness of unknown origin
* drowning or sudden infant death syndrome in a first degree relative
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01947920
Study Brief:
Protocol Section:
NCT01947920