Bioequivalency Study of Sertraline 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2003
Intervention(s) in this Clinical Trial
- Drug: Sertraline
Outcome Measures for this Clinical Trial
Primary Measures
- Bioequivalence
- Time Frame: Baseline, Two period, Fourteen day washout
Safety Issue?: No
- Time Frame: Baseline, Two period, Fourteen day washout
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Roxane Laboratories Industry
Overall Clinical Trial Officials and Contacts
Benoit Girard, MD Principal Investigator Anapharm
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00602849
