At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Donepezil TDS +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Donepezil TDS and Aricept for Healthy Subjects. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionApr 2021
TodayJul 2026
First PostedNov 5, 2020
Enrollment StartDec 8, 2020
Primary CompletionApr 5, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.7 years ago
Interventions
Donepezil TDScombination
Transdermal Delivery System
Ariceptdrug
Oral