Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Completed · Early Phase 1

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01659892

Run by

Roxane Laboratories

People needed

36

Starts

2008-08-01

Expected to finish

2008-08-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if…

• 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.

Where it is running

• PRACS Institute, Ltd. — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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