Back to resultsBioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
Primary Purpose
Asthma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Singulair
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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.
Sites / Locations
- PRACS Institute, Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Montelukast
Singulair
Arm Description
5 mg Chewable Tablet
5 mg Chewable Tablet
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659892
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
5 mg Chewable Tablet
Arm Title
Singulair
Arm Type
Active Comparator
Arm Description
5 mg Chewable Tablet
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair
Intervention Description
5 mg Chewable Tablet
Intervention Type
Drug
Intervention Name(s)
Singulair
Other Intervention Name(s)
Montelukast
Intervention Description
5 mg Chewable Tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan K Copa, PharmD
Organizational Affiliation
PRACS Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRACS Institute, Ltd.
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
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