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

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

• 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

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