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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00944242
First received: July 21, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose
  • Objective:

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

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

Condition Intervention Phase
Healthy
Drug: Sertraline
Drug: Sertraline Hydrochloride
Phase 1

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria
  • 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:

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

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944242

Locations
Canada, Quebec
Anapharm Inc.
Montreal, Quebec, Canada
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00944242     History of Changes
Other Study ID Numbers: 40485
Study First Received: July 21, 2009
Last Updated: July 22, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014