A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males
Phase 1
Completed
- Conditions
- Healthy Elderly Male
- Interventions
- Drug: E2022 Tape Formulation
- Registration Number
- NCT01843556
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E2022 Tape Formulation E2022 Tape Formulation -
- Primary Outcome Measures
Name Time Method Number and frequency of adverse events 168 hours after the end of application
- Secondary Outcome Measures
Name Time Method Time to Reach Maximum Observed Plasma Concentration (Tmax) 216 hours after the end of application Maximal Drug Concentration (CMax) 216 hours after the end of application Area Under the Plasma Concentration-Time Curve (AUC) 216 hours after the end of application Plasma Decay Half-Life (t1/2) 216 hours after the end of application