Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659892
• Other study ID #: MONT-CT5-PVFD-1
• Status: Completed
• Phase: Early Phase 1
• First received: August 6, 2012
• Last updated: January 19, 2018
• Start date: August 2008
• Est. completion date: August 2008

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast
5 mg Chewable Tablet
• Singulair
5 mg Chewable Tablet

Locations

Country	Name	City	State
United States	PRACS Institute, Ltd.	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		9 days