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

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865085
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  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:


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:

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

ClinicalTrials.gov processed this record on July 24, 2014