Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition

NCT01691456 | Completed Phase 1

• 1 other identifier: 539-10
• Study Type: interventional
• Target: 45
• 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)

  Pre-dose (0.00) and 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.

Study Arms (2)

Montelukast Sodium Oral Granules

EXPERIMENTAL

Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited

Drug: Montelukast sodium

SINGULAIR

ACTIVE COMPARATOR

(Montelukast sodium) Oral Granules 4mg of Merck Sharp \& Dohme Ltd., USA

Drug: Montelukast sodium

Interventions

Montelukast sodium DRUG

Montelukast Sodium Oral Granules 4mg

Also known as: SINGULAIR

Montelukast Sodium Oral Granules; SINGULAIR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects within the age range of 18 to 50 years.
• A body mass index between 18.5 to 24.9 Kg/m2
• Given written informed consent to participate in the study.
• Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus and RPR.
• Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
• A normal 12-lead ECG.
• A normal chest X-ray (PA view).
• Compliance with the requirement of the entire protocol.
• No history or no evidence of hypersensitivity to Montelukast and to any component of the formulation.
• No history of gastrointestinal problems (ulcers).
• No history of significant systemic diseases.
• No history of psychiatric disorders.
• No history of allergic rash.
• No history of addiction to any recreational drug or drug dependence.
• No donation of blood (one unit or 350 mL) within 90 days prior to study check in.

You may not qualify if:

• History of seizures.
• Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
• History of alcohol consumption for more than two units/day (1 unit = 30 mL of spirit/or 1 pint of beer), or having consumed alcohol within 48 hours prior to check-in.
• High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day) consumption.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• An unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

AXIS Clinicals Limited,

Hyderabad, Andhra Pradesh, 500 049, India

Location

MeSH Terms

Interventions

montelukast

Study Officials

• A. Jayachandra Reddy, Dr.

  Axis Clinicals 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: September 20, 2012
• First Posted: September 24, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

IN (1)