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Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659892
First Posted: August 8, 2012
Last Update Posted: August 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxane Laboratories
  Purpose
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions

Condition Intervention Phase
Asthma Drug: Montelukast Drug: Singulair Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

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

Enrollment: 36
Study Start Date: August 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
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.
  More Information

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01659892     History of Changes
Other Study ID Numbers: MONT-CT5-PVFD-1
First Submitted: August 6, 2012
First Posted: August 8, 2012
Last Update Posted: August 8, 2012
Last Verified: August 2012

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