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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

March 17, 2009
August 13, 2010
June 2003
July 2003   (final data collection date for primary outcome measure)
Rate and Extend of Absorption [ Time Frame: 168 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions
Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Citalopram HBr 40 mg tablets, single dose
    A: Experimental Subjects received Purepac formulated products under fasting conditions
    Other Name: Citalopram
  • Drug: CelexaTM 40 mg tablets, single dose
    B: Active comparator Subjects received Forest Labs formulated products under fasting conditions
    Other Name: Citalopram
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2003
July 2003   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00865085
CTA-P2-259
No
Meena Venugopal, Director, Clinical R&D, Actavis Inc
Actavis Inc.
Not Provided
Principal Investigator: Eric Sicard,, M.D. Algorithme Pharma Inc
Actavis Inc.
August 2010

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