Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions
|ClinicalTrials.gov Identifier: NCT01419366|
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 23, 2013
To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.
Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Torrent's Donepezil Hydrochloride Tablets 10mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Aricept® (Donepezil Hydrochloride) Tablets 10mg [Reference Formulation, Eisai Inc.), in Healthy Human Volunteers Under Fed Conditions|
- Bioequivalence based on Composite of PharmacokineticsBioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419366
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,|
|Village Bhat, Gandhinagar, Gujarat, India, 382428|