Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Early Phase 1CompletedNCT01659892

Roxane Laboratories36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

MontelukastDRUG

5 mg Chewable Tablet

SingulairDRUG

5 mg Chewable Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PRACS Institute, Ltd.

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 9 days

Data from ClinicalTrials.gov

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