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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00864890
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Actavis Inc.

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 19, 2009
Last Update Posted Date August 17, 2010
Study Start Date  ICMJE June 2003
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2009)
Rate and Extend of Absorption [ Time Frame: 168 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00864890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions
Official Title  ICMJE Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fed State
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 fed conditions.
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/Fed State

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Citalopram HBr 40 mg tablets, single dose
    A: Experimental Subjects received Purepac formulated products under fed conditions
    Other Name: Citalopram
  • Drug: CelexaTM 40 mg tablets, single dose
    B: Active comparator Subjects received Forest Labs formulated products under fed conditions
    Other Name: Citalopram
Study Arms  ICMJE
  • Experimental: A
    Citalopram HBr 40 mg tablets, single dose
    Intervention: Drug: Citalopram HBr 40 mg tablets, single dose
  • Active Comparator: B
    CelexaTM 40 mg tablets, single dose
    Intervention: Drug: CelexaTM 40 mg tablets, single dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2009)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (BMI) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00864890
Other Study ID Numbers  ICMJE CTA-P2-260
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meena Venugopal, Director, Clinical R&D, Actavis Inc
Study Sponsor  ICMJE Actavis Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Sicard, M.D. Algorithme Pharma Inc
PRS Account Actavis Inc.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP