Overview

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.