Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01260948 · ClinicalTrials.gov registry record · Phase 1
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01260948: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01260948 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260948, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.
Primary Outcome
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Interventions
- DRUG Donepezil Hydrochloride
- DRUG Aricept®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
What the finished NCT01260948 record still lists
NCT01260948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Donepezil Hydrochloride is the first listed.
NCT01260948 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01260948 about?
NCT01260948 is a clinical study titled "10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions". This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose...
What is the current status of trial NCT01260948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-04. Estimated completion is 2006-05.
What interventions are being tested in trial NCT01260948?
The interventions under investigation include: Donepezil Hydrochloride (DRUG), Aricept® (DRUG).
Who is sponsoring clinical trial NCT01260948?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01260948's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia