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

• 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sertraline Hydrochloride

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Anapharm Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): July 24, 2009
• Last Update Submitted That Met QC Criteria: July 23, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: 40486