Alzheimers disease
Conditions
Interventions
investigational material(s)
Generic name etc : E2022
INN of investigational material : donepezil
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2: BMI (kg/m2)= weight(kg) / {height(m) X height(m)} 2. Subjects who are between 20 and 55 years of age at the time of obtaining written consent. 3. Subjects who are willing to and can comply with the conditions described in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration. 2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g. alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19, CYP2D6, within 2 weeks before study drug administration. 3. Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation. 4. Subjects who have excessive skin hair around the region to put the patch on. 5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury or scar in the region of patch application, which may have an impact on skin findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets | — |
Outcome results
None listed