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

Official Title: “Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fed 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 fed 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/Fed State

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Intervention(s) in this Clinical Trial

• Drug: Citalopram HBr 40 mg tablets, single dose
  • A: Experimental Subjects received Purepac formulated products under fed conditions
• Drug: CelexaTM 40 mg tablets, single dose
  • B: Active comparator Subjects received Forest Labs formulated products under fed conditions

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Citalopram HBr 40 mg tablets, single dose
• Active Comparator: B
  • CelexaTM 40 mg tablets, single dose

Primary Measures

• Rate and Extend of Absorption
  • Time Frame: 168 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Actavis Inc. Industry

Overall Clinical Trial Officials and Contacts

Eric Sicard, M.D. Principal Investigator Algorithme Pharma Inc  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00864890

Study ID Number: CTA-P2-260

ClinicalTrials.gov Identifier: NCT00864890

Health Authority: United States: Institutional Review Board

Citalopram