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A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®

NCT02968719 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-08-01

No results posted yet for this study

Summary

A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects

Conditions

  • Alzheimer Disease

Interventions

DRUG

Donepezil TDS Version A

Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)

DRUG

Donepezil TDS Version B

Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)

DRUG

Aricept

Aricept (5 mg and 10 mg) Donepezil Hydrochloride

DRUG

Donepezil TDS Version D

Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)

DRUG

Donepezil TDS Version E

Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)

Sponsors & Collaborators

  • Corium, Inc.

    lead INDUSTRY

Principal Investigators

  • Danielle Armas, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-07-11
Completion
2017-07-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968719 on ClinicalTrials.gov