E2022 Patch Formulation Multiple Dose Study
This study has been completed.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: October 4, 2011
Last updated: May 30, 2012
Last verified: May 2012
This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||E2022 Patch Formulation Multiple Dose Phase I Study|
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Composite (or Profile) of Pharmacokinetics [ Time Frame: predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose ] [ Designated as safety issue: No ]Cmax, Area Under Curve, Tmax
|Study Start Date:||September 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: E2020 5 mg tablet and tape||
The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II.
|Placebo Comparator: 2||
Matching Placebo tablets and tape
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