NCT01659918CompletedEarly Phase 1
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fed Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Roxane Laboratories
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- bioequivalence determined by statistical comparison Cmax
Study Overview
Brief Summary
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Montelukast
Active Comparator
10 mg Tablet
Intervention: Montelukast (Drug)
Singulair
Active Comparator
10 mg Tablet
Intervention: Singulair (Drug)
Outcomes
Primary Outcomes
bioequivalence determined by statistical comparison Cmax
Time Frame: 9 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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