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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00946036
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009

July 22, 2009
July 23, 2009
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Complete list of historical versions of study NCT00946036 on ClinicalTrials.gov Archive Site
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Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
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  • 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.
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Interventional
Phase 1
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Healthy
Drug: Sertraline Hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
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Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00946036
40486
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Torrent Pharmaceuticals Limited
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Torrent Pharmaceuticals Limited
July 2009

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