Status:
COMPLETED
E2022 Patch Formulation Single Dose Phase I Study
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Japanese Healthy Male Adult Volunteers
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.
Detailed Description
This study is an open-label single site, randomized single dose study in 80 healthy Japanese male volunteers. The study consists of Period I to Period III, a total of 3 periods. In Period I, E2022 pat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)× height(m)}
- Subjects who are between 20 and 55 years of age at the time of obtaining written consent.
- Subjects who are willing to and can comply with the conditions described in the study protocol.
- Exclusion Criteria
- Subjects who consumed caffeine-containing food or beverages within 72 hours before study drug administration.
- 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.
- Subjects with history of cutaneous hypersensitivity to external preparation, or those who are on another transdermal formulation.
- Subjects who have excessive skin hair around the region to put the patch on.
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01253434
Start Date
November 1 2010
End Date
March 1 2011
Last Update
May 14 2013
Active Locations (1)
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1
Kagoshima, Kagoshima-ken, Japan