Bioequivalency Study of Torsemide Tablets Under Fasting Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting 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.
• History of allergic or adverse response to Torsemide or any comparable or similar product.