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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Citalopram HBr 40 mg tablets, single dose; Drug: CelexaTM 40 mg tablets, single dose

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal,, Quebec, Canada, H4N2Y8
      • Algorithme Pharma Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Citalopram HBr 40 mg tablets, single dose	Drug: Citalopram HBr 40 mg tablets, single dose; A: Experimental Subjects received Purepac formulated products under fed conditions; Other Names: Citalopram
ACTIVE_COMPARATOR: B; CelexaTM 40 mg tablets, single dose	Drug: CelexaTM 40 mg tablets, single dose; B: Active comparator Subjects received Forest Labs formulated products under fed conditions; Other Names: Citalopram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	168 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (ACTUAL): July 1, 2003
• Study Completion (ACTUAL): July 1, 2003

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (ESTIMATE): March 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; Citalopram
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: CTA-P2-260