Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
NCT ID: NCT01659931
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
34 participants
INTERVENTIONAL
2008-02-29
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Montelukast
10 mg Tablet
Montelukast
10 mg Tablet
Singulair
10 mg Tablet
Singulair
10 mg Tablet
Interventions
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Montelukast
10 mg Tablet
Singulair
10 mg Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.
18 Years
45 Years
ALL
Yes
Sponsors
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Roxane Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Alan K Copa, PharmD
Role: PRINCIPAL_INVESTIGATOR
PRACS Institute, Ltd.
Locations
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PRACS Institute, Ltd.
Fargo, North Dakota, United States
Countries
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Other Identifiers
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MONT-T10-PVFS-1
Identifier Type: -
Identifier Source: org_study_id
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