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

NCT00864890 | Completed Phase 1

• 1 other identifier: CTA-P2-260
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Citalopram; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  168 hours

Study Arms (2)

A

EXPERIMENTAL

Citalopram HBr 40 mg tablets, single dose

Drug: Citalopram HBr 40 mg tablets, single dose

B

ACTIVE COMPARATOR

CelexaTM 40 mg tablets, single dose

Drug: CelexaTM 40 mg tablets, single dose

Interventions

Citalopram HBr 40 mg tablets, single dose DRUG

A: Experimental Subjects received Purepac formulated products under fed conditions

Also known as: Citalopram

A

CelexaTM 40 mg tablets, single dose DRUG

B: Active comparator Subjects received Forest Labs formulated products under fed conditions

Also known as: Citalopram

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• Healthy according to the laboratory results and physical examination
• Normal cardiovascular function according to ECG.
• Subjects should be non- or ex-smokers.

You may not qualify if:

• Significant history of hypersensitivity to citalopram or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• 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.
• Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
• Use of MAO inhibitors within 14 days of day 1 of the study
• 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.
• Any clinically significant illness in the previous 28 days before day 1 of this study.
• Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
• Participation in another clinical trial in the previous 28 days before day 1 of this study.
• 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.
• Positive urine screening of drugs of abuse.
• Positive results to HIV, HBsAg or anti-HCV tests
• History of fainting upon blood sampling

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

Algorithme Pharma Inc.

Montreal, Quebec, H4N2Y8, Canada

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eric Sicard, M.D.

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: June 1, 2003
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

CA (1)