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

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.

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 significant depression symptoms or suicidal ideation or behavior as
determined by the Investigator