A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions - Full Text View

Purpose

The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fasting conditions.

Condition	Intervention	Phase
Healthy	Drug: Citalopram HBr 40 mg tablets, single dose Drug: CelexaTM 40 mg tablets, single dose	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State

Resource links provided by NLM:

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Actavis Inc.:

Primary Outcome Measures:

Rate and Extend of Absorption [ Time Frame: 168 hours ] [ Designated as safety issue: No ]


Enrollment:	28
Study Start Date:	June 2003
Study Completion Date:	July 2003
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Citalopram HBr 40 mg tablets, single dose	Drug: Citalopram HBr 40 mg tablets, single dose A: Experimental Subjects received Purepac formulated products under fasting conditions Other Name: Citalopram
Active Comparator: B CelexaTM 40 mg tablets, single dose	Drug: CelexaTM 40 mg tablets, single dose B: Active comparator Subjects received Forest Labs formulated products under fasting conditions Other Name: Citalopram

Detailed Description:

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Eligibility


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
Males aged from 18 to 50 years with a body mass index (8MI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF.
Healthy according to the laboratory results and physical examination
Normal cardiovascular function according to ECG.
Subjects should be non- or ex-smokers.

Exclusion Criteria:

Significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
Use of MAO inhibitors within 14 days of day 1 of the study
Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious Psychological disease.
Any clinically significant illness in the previous 28 days before day 1 of this study.
Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
Participation in another clinical trial in the previous 28 days before day 1 of this study.
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
Positive urine screening of drugs of abuse.
Positive results to HIV, HBsAg or anti-HCV tests
History of fainting upon blood sampling

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865085

Locations


Canada, Quebec
Algorithme Pharma Inc.
Montreal,, Quebec, Canada, H4N2Y8

Sponsors and Collaborators

Actavis Inc.

Investigators


Principal Investigator:	Eric Sicard,, M.D.	Algorithme Pharma Inc

More Information

Additional Information:

Citalopram This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier:	NCT00865085 History of Changes
Other Study ID Numbers:	CTA-P2-259
Study First Received:	March 17, 2009
Last Updated:	August 13, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Actavis Inc.:


Bioequivalence Citalopram Healthy subjects

Additional relevant MeSH terms:


Citalopram Dexetimide Anti-Dyskinesia Agents Antidepressive Agents Antidepressive Agents, Second-Generation Antiparkinson Agents Autonomic Agents Central Nervous System Agents Cholinergic Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action	Muscarinic Antagonists Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Parasympatholytics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015