Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition

NCT01674517 | Completed Phase 1

• 1 other identifier: 742/09
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Montelukast Sodium; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve(AUC)

  Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, hours post-dose.

Study Arms (2)

Montelukast sodium

EXPERIMENTAL

Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited

Drug: Montelukast sodium chewable tablets 4mg and 5mg

SINGULAIR®

ACTIVE COMPARATOR

SINGULAIR®(containing Montelukast sodium) chewable tablets 4mg and 5mg of Merck Sharp \& Dohme Ltd., USA

Drug: Montelukast sodium chewable tablets 4mg and 5mg

Interventions

Montelukast sodium chewable tablets 4mg and 5mg DRUG

Montelukast sodium chewable tablets 4mg and 5mg

Also known as: SINGULAIR®

Montelukast sodium; SINGULAIR®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 I 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)

You may not qualify if:

• 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.
• Prevalence of oral candidiasis, aphthous ulcer or other oral lesions.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Private Limited

Bālānagar, Hyderabad, 500 037, India

Location

MeSH Terms

Interventions

montelukast

Study Officials

• Dwarakanath A, Dr.

  Bioserve Clinical Research Private Limited,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 29, 2012
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

IN (1)