NCT00940238

Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition

A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition

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

Summary

* Objective: * To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting conditions in 36 healthy, adult, human subjects in a randomized crossover study. * Study Design: * Open-label, randomized, two period crossover studies in 36(Fasting)healthy, normal subjects to compare the single dose bioavailability of Torrent's Citalopram Hydrobromide tablets 40 mg and Forest Pharmaceutical's Celexa 40mg tablets.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Citalopram Hydrobromide

Timeline

• First posted: 2009-07-15
• Last updated: 2017-10-24

Locations

1 site across 1 country: India