NCT03432195

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

Detailed description

Randomized, open-label, 3-way crossover study Up to 66 healthy, adult male and female subjects will be enrolled. All subjects will receive Corplex Donepezil TDS patches applied to 3 different locations on each subject (back, buttock, and leg) during 3 different, consecutive treatment periods. For each subject, the location of product administration during each treatment period will be randomized. During each treatment period, all subjects will receive a once-weekly 10 mg TDS, target dose 10 mg donepezil/day, applied for 7 days (1 week) on either the back, buttock, or leg in accordance with the randomized treatment location for that treatment period. Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period. The PK sample collection time points are as follows: Week 1: Pre-TDS application prior to 0 hour and post-TDS application at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 hours. Week 2: Pre-Week 1 TDS removal at 168 hours, and post-TDS removal at up to 528 hours 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

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Donepezil TDS	Donepezil Hydrochloride Transdermal Delivery System

Timeline

• Start date: 2018-01-31
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2018-02-14
• Last updated: 2018-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study