A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Healthy	Drug: Citalopram HBr 40 mg tablets, single dose; Drug: CelexaTM 40 mg tablets, single dose	Phase 1

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Official Title:	Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State
Study Start Date :	June 2003
Actual Primary Completion Date :	July 2003
Actual Study Completion Date :	July 2003

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Rate and Extend of Absorption [ Time Frame: 168 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Healthy according to the laboratory results and physical examination
5. Normal cardiovascular function according to ECG.
6. Subjects should be non- or ex-smokers.

Exclusion Criteria:

1. Significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
2. 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.
3. Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
4. Use of MAO inhibitors within 14 days of day 1 of the study
5. 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.
6. Any clinically significant illness in the previous 28 days before day 1 of this study.
7. Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
8. Participation in another clinical trial in the previous 28 days before day 1 of this study.
9. 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.
10. Positive urine screening of drugs of abuse.
11. Positive results to HIV, HBsAg or anti-HCV tests
12. History of fainting upon blood sampling

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Citalopram 

Responsible Party:	Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier:	NCT00865085 History of Changes
Other Study ID Numbers:	CTA-P2-259
First Posted:	March 19, 2009
Last Update Posted:	August 17, 2010
Last Verified:	August 2010

Keywords provided by Actavis Inc.:

Bioequivalence; Citalopram; Healthy subjects

Additional relevant MeSH terms:

Citalopram; Dexetimide; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation	Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents