Official Title: “A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fasting Conditions”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: July 2003

Intervention(s) in this Clinical Trial

• Drug: Sertraline

Primary Measures

• Bioequivalence
  • Time Frame: Baseline, Two period, Fourteen day washout
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Roxane Laboratories

Overall Clinical Trial Officials and Contacts

Benoit Girard, MD Principal Investigator Anapharm  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00602849

Study ID Number: SERT-01

ClinicalTrials.gov Identifier: NCT00602849

Health Authority: United States: Food and Drug Administration