Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
Overview[ - collapse ][ - ]
Purpose | The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions |
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Condition | Asthma |
Intervention | Drug: Montelukast Drug: Singulair |
Phase | Phase 0 |
Sponsor | Roxane Laboratories |
Responsible Party | Roxane Laboratories |
ClinicalTrials.gov Identifier | NCT01659931 |
First Received | August 6, 2012 |
Last Updated | August 6, 2012 |
Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | August 6, 2012 |
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Last Updated Date | August 6, 2012 |
Start Date | February 2008 |
Estimated Primary Completion Date | February 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 10 mg Tablets Under Fasted Conditions |
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Official Title | A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fasted Conditions |
Brief Summary | The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted 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 10 mg Tablet Other Names: SingulairDrug: Singulair 10 mg Tablet Other Names: Montelukast |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 34 |
Estimated Completion Date | February 2008 |
Estimated Primary Completion Date | February 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 | NCT01659931 |
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Other Study ID Numbers | MONT-T10-PVFS-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, Ltd. |
Verification Date | August 2012 |
Locations[ + expand ][ + ]
PRACS Institute, Ltd. | Fargo, North Dakota, United States, 58104 |
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