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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT01565018
Eligibility Criteria:
Inclusion Criteria:
* Healthy Japanese male and female volunteers with the age between 20 and 55 years old
Exclusion Criteria:
* Subject has participated or is participating in any other clinical studies of investigational drug or another Investigational Medical Product (IMP) within the last 3 months
* Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
* Subject has a QTcB (QT interval corrected for Heart Rate \[HR\] using Bazett´s formula) interval of ≥ 430 ms (≥ 450 ms for females) or any other clinically relevant finding in Electrocardiogram (ECG) at the Eligibility Assessment (EA)
* Subject is having clinically relevant allergy or clinically relevant drug hypersensitivity to any components of the Investigational Medical Product (IMP), or/and having an atopic or eczematous Dermatitis, Psoriasis and/or active skin disease
* Subject has a recent history (within 2 years) of chronic alcohol or drug abuse and has a history of significant skin hypersensitivity to transdermal products, and of an atopic or eczematous Dermatitis, Psoriasis, and/or active skin disease and have a history of suicide attempt, Epilepsy and/or seizures
* Subject has made a blood donation or a comparable blood loss within the last 3 months prior to the Eligibility Assessment (EA)
* Subject is pregnant or nursing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01565018
Study Brief:
Protocol Section:
NCT01565018