A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery… (NCT03432195) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplexâ„¢ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
United States66 participantsStarted 2018-01-31
Plain-language summary
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplexâ„¢ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy, adult, male or female
* Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator
* Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type
Key Exclusion Criteria:
* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)
* Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms
* Potential for occupational exposure to anticholinesterase agents
* Estimated creatinine clearance in non-elderly subjects \<80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) \<60 mL/min at screening
* Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
* Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
* History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
* Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration
* Clinically sig…
What they're measuring
1
Pharmacokinetics, AUC
Timeframe: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total
2
Pharmacokinetics, CMAX
Timeframe: Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total