Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Montelukast sodium

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Hyderabad
    • Balanagar, Hyderabad, India, 500 037
      • Bioserve Clinical Research Private Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast sodium tablets; Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited	Drug: Montelukast sodium; Montelukast sodium tablets 10mg; Other Names: SINGULAIR
Active Comparator: SINGULAIR; (containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA	Drug: Montelukast sodium; Montelukast sodium tablets 10mg; Other Names: SINGULAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve(AUC)	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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Bioequivalence; crossover; Montelukast Sodium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 615/10