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Trial record 93 of 485 for:    ESCITALOPRAM AND Antagonists

Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01149980
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE June 21, 2010
First Posted Date  ICMJE June 24, 2010
Last Update Posted Date June 24, 2010
Study Start Date  ICMJE October 2003
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2010)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 2 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
Official Title  ICMJE Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions
Brief Summary This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fed conditions.
Detailed Description

randomized, 2-way crossover; bioequivalence study of citalopram hydrobromide 40 mg tablets and celexa 40 mg tablets administered as

1 x 40 mg tablet in healthy subjects under fed conditions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Citalopram Hydrobromide
Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited
Other Name: Celexa Tablets 40 mg
Study Arms  ICMJE
  • Experimental: Citalopram
    Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's
    Intervention: Drug: Citalopram Hydrobromide
  • Active Comparator: Celexa
    Celexa 40 mg Tablets of Forest Labs
    Intervention: Drug: Citalopram Hydrobromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2010)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2003
Actual Primary Completion Date November 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Inc.Web site, Anaphann Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:

  • Non-child-bearing potential female or simale, smokers and/or non-smoker, 18 years of age and older.
  • Subjects capable of consent
  • Non-child-bearing potential female subject:
  • Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
  • Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.

Exclusion Criteria:

  • Subjects to whom any of the following applies will be excluded from the study:

    • Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
    • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
    • Any clinically significant abnormality found during medical screening.
    • Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
    • Abnormal laboratory tests judged clinically significant.
    • Positive urine drug screen at screening.
    • Positive testing for hepatitis B, hepatitis C, or Human Immunodeficiency Virus HIV) at screening.
    • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm)at screening.
    • Subjects with Body Mass Index (BMI) 2:30.0.
    • History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
    • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP]and crack) within 1 year prior to the screening visit.
    • History of allergic reactions to citalopram hydrobromide or other related drugs.
    • History of allergic reactions to heparin.
    • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, Mono Amine Oxidase (MAO) inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
    • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
    • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases). Unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
    • Any clinically significant history or presence of clinically significant neurological,endocrinal, cardiovascular, pulmonary, hematologic, immunologic psychiatric or metabolic disease.
    • Use of prescription medication (including hormone therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
    • Smoking more than 25 cigarettes per day.
    • Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Sub-Investigator, contraindicate the subject's participation in this study.
    • A depot injection or an implant of any drug within 3 months prior to administration of study medication.
    • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
    • less than 300 mL of whole blood within 30 days,
    • 300 mL to 500 mL of whole blood within 45 days or
    • more than 500 mL of whole blood within 56 days prior to drug administration.
    • Consumption of food or beverages containing grapefruit (e.g. fresh, canned or frozen)within 7 days prior to administration of the study medication.
    • History of seizure disorder or bipolar affective disorder.
    • Active psychiatric diagnosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01149980
Other Study ID Numbers  ICMJE 30285
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.Ramakrishna Banagaru, Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benoit Girard, M.D Anapharm. Clinical Laboratory
PRS Account Dr. Reddy's Laboratories Limited
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP