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Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01659892
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Brief Summary:
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast Drug: Singulair Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Montelukast
5 mg Chewable Tablet
Drug: Montelukast
5 mg Chewable Tablet
Other Name: Singulair
Active Comparator: Singulair
5 mg Chewable Tablet
Drug: Singulair
5 mg Chewable Tablet
Other Name: Montelukast



Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659892


Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Alan K Copa, PharmD PRACS Institute, Inc.

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01659892     History of Changes
Other Study ID Numbers: MONT-CT5-PVFD-1
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action