drugset / Trial / NCT01260948

10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions

NCT01260948 ↗

Phase 1 Completed 26 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

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.

Timeline

Start
2006-04
Primary completion
2006-05
Completion
2006-05

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 98.72 (90% CI 94.13 to 103.53) NCT01260948 ↗

registry Ratio of the T/R geometric mean x 100 94.81 (90% CI 91.30 to 98.47) NCT01260948 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 10 mg Oral

Indications

No indication recorded.