A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00865085 |
Recruitment Status
:
Completed
First Posted
: March 19, 2009
Last Update Posted
: August 17, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Citalopram HBr 40 mg tablets, single dose Drug: CelexaTM 40 mg tablets, single dose | Phase 1 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | July 2003 |
Actual Study Completion Date : | July 2003 |
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 fasting conditions
Other Name: 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 fasting conditions
Other Name: Citalopram
|
- Rate and Extend of Absorption [ Time Frame: 168 hours ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 (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.
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865085
Canada, Quebec | |
Algorithme Pharma Inc. | |
Montreal,, Quebec, Canada, H4N2Y8 |
Principal Investigator: | Eric Sicard,, M.D. | Algorithme Pharma Inc |
Additional Information:
Responsible Party: | Meena Venugopal, Director, Clinical R&D, Actavis Inc |
ClinicalTrials.gov Identifier: | NCT00865085 History of Changes |
Other Study ID Numbers: |
CTA-P2-259 |
First Posted: | March 19, 2009 Key Record Dates |
Last Update Posted: | August 17, 2010 |
Last Verified: | August 2010 |
Keywords provided by Actavis Inc.:
Bioequivalence Citalopram Healthy subjects |
Additional relevant MeSH terms:
Citalopram Dexetimide Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |