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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT01843556
Eligibility Criteria:
Inclusion criteria:
1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
3. Written informed consent
4. Given full explanation of this study and is willing to and able to comply with the protocol requirements
Exclusion criteria:
1. Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
2. Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality
3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I
6. Had nutritional supplements, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage) which may affect drug metabolizing enzymes and transporters, within 1 weeks before Period I
7. Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1
8. Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis
9. Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
10. Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
65 Years
Study:
NCT01843556
Study Brief:
Protocol Section:
NCT01843556