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

Alzheimer's Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT03432195
• Study type: Interventional
• Source: Corium International Inc.
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2018
• Completion date: June 28, 2018