Bioequivalency Study of Sertraline Under Fed Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fed Conditions

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.

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.