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OpenTrials
Completed

NCT Number: NCT00946036

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.

Completed

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Key information

Conditions

Study type

Interventional

Phase

Phase 1

Primary location

Anapharm Inc.

Montreal, Quebec, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sertraline hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Torrent Pharmaceuticals Limited

Industry

Registry information

Important dates

First posted
Jul 24, 2009
Registry last updated
Jul 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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