NCT01506739CompletedPhase 1
A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 12
- Primary Endpoint
- PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Study Overview
Brief Summary
The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5 g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated tablet (5 mg) in Japanese healthy adult males.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Active Comparator
Intervention: Donepezil Hydrochloride (Drug)
2
Active Comparator
Intervention: Donepezil Hydrochloride (Drug)
3
Active Comparator
Intervention: Donepezil Hydrochloride (Drug)
Outcomes
Primary Outcomes
PK Parameter Cmax, calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Time Frame: Up to 168 hrs after administration
PK Parameter AUC (0-168), calculated from plasma E2020 concentration by a non-compartmental analysis, will be evaluated.
Time Frame: Up to 168 hrs after administration
Secondary Outcomes
No secondary outcomes reported
Investigators
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