A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System

• Status: Completed
• Trial end date: 2018-04-02
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corium International Inc.; Corium, Inc.
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Healthy, adult, male or female

• Body mass index ≥ 18.0 and ≤ 35.0 kg/m2

• Medically healthy, as deemed by the Investigator

• Have a skin type with Fitzpatrick scale score of I, II, or III

Exclusion Criteria:

• History or presence of alcoholism or drug abuse

• History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds

• Positive urine drug or alcohol results

• Female subjects with a positive pregnancy test or who are lactating

• Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:

1. Inducers of cytochrome enzymes and/or P-glycoprotein

2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics

3. Beta-blockers

4. Cholinergics and anticholinergics

5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications

• History or presence of significant skin damage deemed by the investigator to potentially interfere

• Any medical or surgical procedure or trauma

• Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment