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Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Montelukast sodium
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Bioequivalence, Montelukast Sodium, crossover

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Subjects were selected based on the following inclusion criteria:

  • Provide written informed consent.
  • Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
  • Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 .
  • Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
  • Female Subjects

    • Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
    • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

The subjects were excluded based on the following criteria during screening and during the study:

  • Incapable of understanding the informed consent.
  • Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
  • Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
  • Oral temperature is below 95.0°F or above 98.6°F.
  • Pulse rate below 50/min or above 100/min.
  • History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
  • Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
  • Consumption of grapefruit for the past ten days prior to the check-in, in each period.
  • Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
  • Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
  • Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
  • Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
  • Clinically significant abnormalities and / or with significant diseases.
  • Confirmed positive in alcohol screening.
  • Confirmed positive in selected drug of abuse.
  • Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
  • Confirmed positive in urine pregnancy test.
  • Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.

Sites / Locations

  • Bioserve Clinical Research Private Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Montelukast sodium tablets

SINGULAIR

Arm Description

Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited

(containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA

Outcomes

Primary Outcome Measures

Area under curve(AUC)

Secondary Outcome Measures

Full Information

First Posted
August 21, 2012
Last Updated
August 22, 2012
Sponsor
Dr. Reddy's Laboratories Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01671722
Brief Title
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
Official Title
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Detailed Description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fed conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Bioequivalence, Montelukast Sodium, crossover

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast sodium tablets
Arm Type
Experimental
Arm Description
Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited
Arm Title
SINGULAIR
Arm Type
Active Comparator
Arm Description
(containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA
Intervention Type
Drug
Intervention Name(s)
Montelukast sodium
Other Intervention Name(s)
SINGULAIR
Intervention Description
Montelukast sodium tablets 10mg
Primary Outcome Measure Information:
Title
Area under curve(AUC)
Time Frame
Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects were selected based on the following inclusion criteria: Provide written informed consent. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 . Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance). Female Subjects Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) Exclusion Criteria The subjects were excluded based on the following criteria during screening and during the study: Incapable of understanding the informed consent. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Oral temperature is below 95.0°F or above 98.6°F. Pulse rate below 50/min or above 100/min. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Consumption of grapefruit for the past ten days prior to the check-in, in each period. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period. Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing. Clinically significant abnormalities and / or with significant diseases. Confirmed positive in alcohol screening. Confirmed positive in selected drug of abuse. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study. Confirmed positive in urine pregnancy test. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vimal Teja P, Dr.
Organizational Affiliation
Bioserve Clinical Research Private Limited,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bioserve Clinical Research Private Limited
City
Balanagar
State/Province
Hyderabad
ZIP/Postal Code
500 037
Country
India

12. IPD Sharing Statement

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Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition

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