Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Montelukast

Drug

Chewable Tablet

Other names: Singulair

Singulair

Drug

5 mg Chewable Tablet

Other names: Montelukast

Primary outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 8, 2012
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed