Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions

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 montelukast or any comparable or similar product.