Bioequivalency Study of Sertraline Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Sertraline (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Benoit Girard, MD, Principal Investigator, Affiliation: Anapharm
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.
Clinical Details
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Anapharm Inc., Sainte-Fly, Quebec, Canada
Additional Information
Starting date: June 2003
Ending date: July 2003
Last updated: February 5, 2008
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