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Bioequivalence Study of Montelukast 5 mg Chewable

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Montelukast 5 mg chewable tablets

About this trial

This is an interventional other trial for Asthma focused on measuring Bioequivalence, Mexico, Asthma, Montelukast, Chewable

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss => 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A(reference)/B(test)

B(test)/A(reference)

Arm Description

initial administration of reference and cross-over to test

initial administration of test and cross-over to reference

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (CMAX) of montelukast

Pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of montelukast

Pharmacokinetics

Secondary Outcome Measures

Full Information

NCT ID

NCT01863654

First Posted

May 23, 2013

Last Updated

June 13, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01863654

Brief Title

Bioequivalence Study of Montelukast 5 mg Chewable

Official Title

Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Chewable Tablets of Montelukast 5 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair™, Merck Sharp & Dohme de México, S.A. de C.V.) in Fasting Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 16, 2010 (Actual)

Primary Completion Date

May 26, 2010 (Actual)

Study Completion Date

May 26, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable tablets; Merck Sharp & Dohme). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Bioequivalence, Mexico, Asthma, Montelukast, Chewable

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A(reference)/B(test)

Arm Type

Experimental

Arm Description

initial administration of reference and cross-over to test

Arm Title

B(test)/A(reference)

Arm Type

Experimental

Arm Description

initial administration of test and cross-over to reference

Intervention Type

Drug

Intervention Name(s)

Montelukast 5 mg chewable tablets

Other Intervention Name(s)

Singulair, Merck Sharp & Dohme de Mexico SA de CV

Intervention Description

Reference product

Intervention Type

Drug

Intervention Name(s)

Montelukast 5 mg chewable tablets

Intervention Description

Test product

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (CMAX) of montelukast

Description

Pharmacokinetics

Time Frame

0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage

Title

Area under the plasma concentration versus time curve (AUC) of montelukast

Description

Pharmacokinetics

Time Frame

0.0, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18, and 22 hours postdosage

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) - Exclusion Criteria: Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study. Requirement of any kind of medication during the course of the study, except study medication. History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. Hospitalization for any cause in the seven months before the beginning of the study. Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. Blood donation or loss => 450 ml in the 60 days before the beginning of the study. History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

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Bioequivalence Study of Montelukast 5 mg Chewable

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