Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition
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|ClinicalTrials.gov Identifier: NCT01996462|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) [Reference formulation, Forest Laboratories Inc, USA] . Dosing periods were separated by a washout period during fasted study.
Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Escitalopram Oxalate Tablets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet Containing Escitalopram (20mg) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® Tablet (20mg) [Reference Formulation, Forest Laboratories, USA] in Healthy Human Volunteers Under Fasting Condition|
|Actual Primary Completion Date :||May 2008|
|Experimental: Torrent's of Escitalopram Oxalate Tablet 20 mg||
Drug: Escitalopram Oxalate Tablets
- bioequivalence based on Composite of Pharmacokinetics [ Time Frame: plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00, 18.00 and 24.00 hours after dose administration ]bioequivalence; 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996462
|Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.|
|Village Bhat, Gandhinagar, Gujarat, India, 382428|