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Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

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.
 
ClinicalTrials.gov Identifier: NCT01659905
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 )

Tracking Information
First Submitted Date  ICMJE August 6, 2012
First Posted Date  ICMJE August 8, 2012
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions
Official Title  ICMJE A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions
Brief Summary The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Montelukast
    Chewable Tablet
    Other Name: Singulair
  • Drug: Singulair
    5 mg Chewable Tablet
    Other Name: Montelukast
Study Arms  ICMJE
  • Active Comparator: Montelukast
    5 mg Chewable Tablet
    Intervention: Drug: Montelukast
  • Active Comparator: Singulair
    5 mg Chewable Tablet
    Intervention: Drug: Singulair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659905
Other Study ID Numbers  ICMJE MONT-CT5-PVFS-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party West-Ward Pharmaceutical ( Roxane Laboratories )
Study Sponsor  ICMJE Roxane Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan K Copa, PharmD PRACS Institute, Ltd.
PRS Account West-Ward Pharmaceutical
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP