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

NCT ID: NCT00864890

Last Updated: 2010-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2003-07-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Citalopram HBr 40 mg tablets, single dose

Group Type: EXPERIMENTAL

Citalopram HBr 40 mg tablets, single dose

Intervention Type: DRUG

A: Experimental Subjects received Purepac formulated products under fed conditions

B

CelexaTM 40 mg tablets, single dose

Group Type: ACTIVE_COMPARATOR

CelexaTM 40 mg tablets, single dose

Intervention Type: DRUG

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

Interventions

Citalopram HBr 40 mg tablets, single dose

A: Experimental Subjects received Purepac formulated products under fed conditions

Intervention Type: DRUG

CelexaTM 40 mg tablets, single dose

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

Intervention Type: DRUG

Other Intervention Names

Citalopram; Citalopram

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Eric Sicard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

Algorithme Pharma Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CTA-P2-260

Identifier Type: -

Identifier Source: org_study_id