NCT01253434

E2022 Patch Formulation Single Dose Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Japanese Healthy Male Adult Volunteers

Interventions

Type	Name	Description
DRUG	E2022	E2022 Type A patch
DRUG	E2022	E2022 Type B patch
DRUG	E2022	E2022 Type C patch
DRUG	E2022	E2022 Type D patch
DRUG	E2022	E2022 Type E patch

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-12-03
• Last updated: 2013-05-14

Locations

1 site across 1 country: Japan