Trials / Completed
CompletedNCT03259958
A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Corium, Inc. · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Accepted
Summary
A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®
Detailed description
Open label, randomized, 2-period, multiple-dose crossover study. Approximately 86 healthy, adult male and female subjects will be enrolled. Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1. For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10. Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donepezil TDS | Donepezil Hydrochloride Transdermal Delivery System |
| DRUG | Aricept | Aricept Tablet |
Timeline
- Start date
- 2017-10-30
- Primary completion
- 2018-03-13
- Completion
- 2018-03-14
- First posted
- 2017-08-24
- Last updated
- 2018-08-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03259958. Inclusion in this directory is not an endorsement.