Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

Early Phase 1CompletedNCT01659931

Roxane Laboratories34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

MontelukastDRUG

10 mg Tablet

SingulairDRUG

10 mg 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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