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NCT04617782 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers
A Phase 1 study, sponsored by Corium.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT04617782: Completed Phase 1 study, sponsored by Corium.
NCT04617782 is a Phase 1 study that has completed, run by Corium. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04617782, a Phase 1 study, has completed, sponsored by Corium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Interventions
- DRUG Aricept
- COMBINATION_PRODUCT Donepezil TDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2021-04-05 |
| Phase | Phase 1 |
What the finished NCT04617782 record still lists
NCT04617782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Aricept is the first listed.
NCT04617782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04617782 about?
NCT04617782 is a clinical study titled "Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers". 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.
What is the current status of trial NCT04617782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-12-08. Estimated completion is 2021-04-05.
What interventions are being tested in trial NCT04617782?
The interventions under investigation include: Aricept (DRUG), Donepezil TDS (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04617782?
This trial is sponsored by Corium, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04617782's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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