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Bioequivalency Study of Sertraline Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00601588
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 23, 2018
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.

Condition or disease Intervention/treatment
Depression Drug: Sertraline

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions
Study Start Date : June 2003
Primary Completion Date : July 2003
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, Two period, Fourteen day washout ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • Treatment with any triptan within 30 days prior to or during the study.
  • History of allergic or adverse response to sertraline or any comparable or similar product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601588

Canada, Quebec
Anapharm Inc.
Sainte-Fly, Quebec, Canada
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Benoit Girard, MD Anapharm

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00601588     History of Changes
Other Study ID Numbers: SERT-02
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs