E2022 Patch Formulation Single Dose Phase I Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 80
- Primary Endpoint
- Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
Study Overview
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 patches will be secured with seal. In Period II, single dose of E2022 5 mg tablet will be administered. In Period III, E2022 patches will be applied without seal. The features of the 5 patches will be evaluated in this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
4
Intervention: E2022 (Drug)
2
Intervention: E2022 (Drug)
1
Intervention: E2022 (Drug)
5
Intervention: E2022 (Drug)
3
Intervention: E2022 (Drug)
Outcomes
Primary Outcomes
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.
Time Frame: 15 days
Secondary Outcomes
No secondary outcomes reported