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Sponsored by: |
Roxane Laboratories |
Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00601588 |
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 | Intervention |
Depression |
Drug: Sertraline |
MedlinePlus related topics: | Depression |
Drug Information available for: | Sertraline hydrochloride Sertraline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions |
Enrollment: | 43 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | SERT-02 |
First Received: | January 15, 2008 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00601588 |
Health Authority: | United States: Food and Drug Administration |
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