Crossover Pharmacokinetic (PK) Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-04-05
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1, open-label, randomized, 3-period, 3-treatment, crossover pharmacokinetic study to evaluate the steady-state pharmacokinetics of 5 mg/day and 10 mg/day Corplex™ Donepezil TDS manufactured with the commercial process compared to 10 mg Aricept® in healthy volunteers.

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

Details

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

Criteria

Inclusion Criteria:

• Healthy males and females.

• Subject's Body Mass Index (BMI) must be between 18 and 32 kg/m2 (inclusive).

• Subject must be continuous non-smokers.

• Subject must have a Fitzpatrick skin type of I, II or III.

Exclusion Criteria:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.

• After resting seated for at least 3 minutes, subjects should be excluded from the study with the following vital signs at Screening

1. systolic blood pressure outside the range of 90-145 mmHg, or

2. diastolic blood pressure outside the range of 50-90 mmHg, or

3. resting heart rate outside the range of 40-100 beats per minute.

• Has an isolated ALT ≥1.5x the ULN or AST ≥1.5x the ULN at Screening; or both ALT and AST exceeding the ULN.

• Estimated creatinine clearance at screening <70 mL/min/1.73 m2.

• Prolonged corrected QTcF on screening ECG (≥450 ms for both females and males).

• History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with patch adhesion or drug absorption.

• History or presence of significant skin damage, diffuse skin diseases-, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or skin tolerability assessments

• Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration.

• Has participated in another clinical trial within 30 days prior to Day -1.