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NCT01260922 · ClinicalTrials.gov registry record · Phase 1
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01260922: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
NCT01260922 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy 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
NCT01260922, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This study investigated the relative bioavailability (rate and extent 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 fasting conditions.
Primary Outcome
Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).
Conditions Studied
Interventions
- DRUG Donepezil Hydrochloride
- DRUG Aricept®
Study Locations (1)
Minnesota
- PRACS Institute, Ltd. - East Grand Forks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-04 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
What the finished NCT01260922 record still lists
NCT01260922 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Donepezil Hydrochloride is the first listed.
NCT01260922 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01260922 about?
NCT01260922 is a clinical study titled "10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.". This study investigated the relative bioavailability (rate and extent 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 NCT01260922?
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 conditions does trial NCT01260922 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01260922?
The interventions under investigation include: Donepezil Hydrochloride (DRUG), Aricept® (DRUG).
Who is sponsoring clinical trial NCT01260922?
This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01260922 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT01260922's enrollment target sits among peer trials
26 760th of 1090 higher than 314 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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