NCT04617782

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

A Phase 1, Open-Label, 3-Period, Randomized, Crossover Pharmacokinetic Study to Evaluate the Steady-State Pharmacokinetics of 5 mg and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Oral Aricept® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Screening Period: Subjects will undergo a Screening Period up to 28 days prior to entering the Treatment Phase. Treatment Phase consisting of 3 Treatment periods with 3 Treatments A, B, C. Treatment Period 1: All Subjects will receive Treatment A; 5 mg/day Donepezil Transdermal Delivery System (TDS); 1-week wear and applied for 5 consecutive weeks. Treatment Periods 2 and 3: Subjects will be randomized (by gender) to receive either sequences of Treatments B-C or Treatments C-B. Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks Treatment C: 10 mg/day Aricept® donepezil tablet administered daily (QD) for 5 weeks. Blood samples for pharmacokinetics and safety assessments will be collected during the Treatment Phase.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Donepezil TDS	Transdermal Delivery System
DRUG	Aricept	Oral

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2020-11-05
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study