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NCT02968719 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®
A Phase 1 study of Alzheimer Disease, sponsored by Corium.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
- 1
- Study location
NCT02968719: Completed Phase 1 study of Alzheimer Disease, sponsored by Corium.
NCT02968719 is a Phase 1 study of Alzheimer Disease that has completed, run by Corium. The registered enrollment target is 107 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02968719, a Phase 1 study of Alzheimer Disease, has completed, sponsored by Corium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects
Primary Outcome
To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept. Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)
Conditions Studied
Interventions
- DRUG Donepezil TDS Version A
- DRUG Donepezil TDS Version B
- DRUG Aricept
- DRUG Donepezil TDS Version D
- DRUG Donepezil TDS Version E
Study Locations (1)
Arizona
- Celerion - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-07-11 |
| Phase | Phase 1 |
What the finished NCT02968719 record still lists
NCT02968719 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 5 interventions - of which Donepezil TDS Version A is the first listed.
NCT02968719 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02968719 about?
NCT02968719 is a clinical study titled "A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®". A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects
What is the current status of trial NCT02968719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2016-11. Estimated completion is 2017-07-11.
What conditions does trial NCT02968719 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT02968719?
The interventions under investigation include: Donepezil TDS Version A (DRUG), Donepezil TDS Version B (DRUG), Aricept (DRUG), Donepezil TDS Version D (DRUG), Donepezil TDS Version E (DRUG).
Who is sponsoring clinical trial NCT02968719?
This trial is sponsored by Corium, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02968719 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02968719's enrollment target sits among peer trials
107 147th of 306 higher than 160 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease 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.
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