Status:
COMPLETED
A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
Lead Sponsor:
Corium, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
Brief Summary
A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)
Detailed Description
2-Way Crossover study Approximately 24 healthy, adult male and female subjects will be enrolled. Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treat...
Eligibility Criteria
Inclusion
- Healthy, adult, male or female ≥ 30 years of age
Exclusion
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
- History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
- History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
- History or presence of excessive sweating
- History or presence of hairy skin on application sites
- History or presence of significant skin damage or disease at application sites
- Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03438604
Start Date
February 13 2018
End Date
June 30 2018
Last Update
September 14 2018
Active Locations (1)
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1
Celerion
Phoenix, Arizona, United States, 85283