Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Montelukast

Criteria

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.