Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions | RxWiki

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Overview[ - collapse ][ - ]

Purpose	The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
Condition	Asthma
Intervention	Drug: Montelukast Drug: Singulair
Phase	Phase 0
Sponsor	Roxane Laboratories
Responsible Party	Roxane Laboratories
ClinicalTrials.gov Identifier	NCT01659892
First Received	August 6, 2012
Last Updated	August 7, 2012
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	August 6, 2012
Last Updated Date	August 7, 2012
Start Date	August 2008
Estimated Primary Completion Date	August 2008
Current Primary Outcome Measures	bioequivalence determined by statistical comparison Cmax [Time Frame: 9 days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
Official Title	A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fed Conditions
Brief Summary	The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 0
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: Montelukast 5 mg Chewable Tablet Other Names: SingulairDrug: Singulair 5 mg Chewable Tablet Other Names: Montelukast
Study Arm (s)	Active Comparator: Montelukast 5 mg Chewable Tablet Active Comparator: Singulair 5 mg Chewable Tablet

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	36
Estimated Completion Date	August 2008
Estimated Primary Completion Date	August 2008
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01659892
Other Study ID Numbers	MONT-CT5-PVFD-1
Has Data Monitoring Committee	No
Information Provided By	Roxane Laboratories
Study Sponsor	Roxane Laboratories
Collaborators	Not Provided
Investigators	Principal Investigator: Alan K Copa, PharmD PRACS Institute, Inc.
Verification Date	August 2012

Locations[ + expand ][ + ]