Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01671709
First received: August 21, 2012
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.


Condition Intervention Phase
Healthy
Drug: Montelukast sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area under curve(AUC) [ Time Frame: Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast sodium tablets
Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited
Drug: Montelukast sodium
Montelukast sodium tablets 10mg
Other Name: SINGULAIR
Active Comparator: SINGULAIR
(containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA
Drug: Montelukast sodium
Montelukast sodium tablets 10mg
Other Name: SINGULAIR

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 fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671709

Locations
India
Bioserve Clinical Research Private Limited
Balanagar, Hyderabad, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Vimal Teja P, Dr. Bioserve Clinical Research Private Limited,
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01671709     History of Changes
Other Study ID Numbers: 615/10
Study First Received: August 21, 2012
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Montelukast Sodium
crossover

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

ClinicalTrials.gov processed this record on April 17, 2014