E2022 Patch Formulation Single Dose Phase I Study

Phase 1

Completed

• Conditions: Japanese Healthy Male Adult Volunteers
• Interventions: Drug: E2022

• Registration Number: NCT01253434
• Lead Sponsor: Eisai Co., Ltd.

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	E2022	-
3	E2022	-
1	E2022	-
2	E2022	-
5	E2022	-

Primary Outcome Measures

Name	Time	Method
Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.	15 days