NCT01996462

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fasting Condition

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Objective: 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. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Escitalopram Oxalate Tablets

Timeline

• Primary completion: 2008-05-01
• First posted: 2013-11-27
• Last updated: 2013-11-27

Locations

1 site across 1 country: India