NCT00864890

CompletedPhase 1

A Relative Bioavailability Study of Citalopram 40 mg Tablets...

Actavis Inc.Source

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Other study identifiers

Sponsor study identifier

CTA-P2-260

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2003

Actual (reported)

Study Completion

July 2003

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: July 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2003
Actual (reported)
Study Completion
July 2003
Actual (reported)
First Submitted
March 17, 2009
Actual (reported)
First Posted
March 19, 2009
Actual (reported)

Last Updated: August 17, 2010
Status Verified: August 2010
Last Update Submitted: August 13, 2010

Conditions

Healthy

Keywords

BioequivalenceCitalopramHealthy 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 doseDrug

A: Experimental Subjects received Purepac formulated products under fed conditions

Also known as: Citalopram

A

CelexaTM 40 mg tablets, single doseDrug

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

Also known as:

Eligibility Criteria

Age18 Years - 50 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Actavis Inc.
Industrylead

Study Sites (1)

Algorithme Pharma Inc.

Montreal, Quebec, H4N2Y8, Canada

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Eric Sicard, M.D.
Algorithme Pharma Inc
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

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 2003

Date type not reported

This date has not been verified as actual or estimated.

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Citalopram

B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Contact the study team to confirm eligibility.

Primary Completion

July 2003

Actual (reported)

Study Completion

July 2003

Actual (reported)

Last Updated

August 17, 2010

Record last verified: 2010-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00864890
Data provider: ClinicalTrials.gov
Source updated: 2010-08-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:33 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations