Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Montelukast Chewable 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.