CClinicalTrials.gg
CompletedNCT00946036Updated Jul 24, 2009

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

A Phase 1 interventional study of Sertraline Hydrochloride in Healthy, sponsored by Torrent Pharmaceuticals Limited. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2009-07-24.

Sponsored by Torrent Pharmaceuticals Limited · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
01

Study 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Torrent Pharmaceuticals Limited is the lead sponsor of 71 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)

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

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.
05

Study design

Phase
Phase 1

Interventions

  • DrugSertraline Hydrochloride
06

Study locations

1 site
  • Anapharm Inc.
    Montreal, Quebec, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00946036
Lead sponsor
Torrent Pharmaceuticals Limited
First posted
Jul 24, 2009
Last update
Jul 24, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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