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Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946036
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Information provided by:
Torrent Pharmaceuticals Limited

Brief Summary:
  • Objective:

    • To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
  • Study Design:

    • Single-dose, open-label, randomized two-way crossover.

Condition or disease Intervention/treatment Phase
Healthy Drug: Sertraline Hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

Inclusion Criteria:

  • Male or female, smoker or non smoker, 18 years of age and older.
  • Capable of consent.
  • BMI>= 19.0 and <30.0 kg/m2

Exclusion Criteria:

  • Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities or vital sign abnormalities(blood pressure).
  • History of significant alcohol or drug abuse within one year prior to the screening visit.
  • History or allergic reactions to heparin, sertraline or other related drugs.
  • Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
  • Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
  • History of seizures, suicide attempt, bipolar disorder or manic episodes.
  • Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
  • Breastfeeding subject.
  • Positive urine pregnancy test at screening.
  • Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception:

    1. Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
    2. Condom or diaphragm + spermicide.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00946036

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Canada, Quebec
Anapharm Inc.
Montreal, Quebec, Canada
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
Layout table for additonal information Identifier: NCT00946036    
Other Study ID Numbers: 40486
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs