Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

Early Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Montelukast; Drug: Singulair

• Registration Number: NCT01659905
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Montelukast	Montelukast	5 mg Chewable Tablet
Singulair	Singulair	5 mg Chewable Tablet

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	9 days

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States