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

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ClinicalTrials.gov Identifier: NCT00865085
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Actavis Inc.

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

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Citalopram  This link exits the ClinicalTrials.gov site

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    Key Record Dates
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