Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01659905
First received: August 6, 2012
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.


Condition Intervention Phase
Asthma
Drug: Montelukast
Drug: Singulair
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 Fasted 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 ] [ Designated as safety issue: No ]

Enrollment: 35
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
Chewable Tablet
Other Name: Singulair
Active Comparator: Singulair
5 mg Chewable Tablet
Drug: Singulair
5 mg Chewable Tablet
Other Name: Montelukast

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659905

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, Ltd.
  More Information

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01659905     History of Changes
Other Study ID Numbers: MONT-CT5-PVFS-1
Study First Received: August 6, 2012
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014