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 in Fed Condition
Summary
- Objective:
- The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition
- Study Design:
- Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequivalence Study comparing Citalopram Hydrobromide Tablets 40 mg (manufactured by Torrent Pharmaceuticals Ltd). With RLD Tablets 40 mg (manufactured by Forest Pharmaceuticals Inc Missouri) in 24+2 normal healthy male subjects with a wash out period of 15 days between the two study periods, in fed condition.
Study Design
N/A
Conditions
Healthy
Intervention
Citalopram Hydrobromide
Location
Accutest Research Laboratories Pvt. Ltd.
Mumbai
Maharashtra
India
400 709
Status
Completed
Source
Torrent Pharmaceuticals Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00939835
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Citalopram
A furancarbonitrile that is one of the SEROTONIN UPTAKE INHIBITORS used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from tardive dyskinesia in preference to tricyclic antidepressants, which aggravate this condition.
Clinical Trials
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PubMed Articles
A Critical Evaluation of the Cardiac Toxicity of Citalopram: Part 1.
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A Critical Evaluation of the Cardiac Toxicity of Citalopram: Part 2.
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We describe the synthesis and the pharmacological characterization of a new quaternary selective serotonin reuptake inhibitor (SSRI) N-methyl-citalopram (NMC) with periphery restricted action due to i...
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