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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691456
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Montelukast sodium Phase 1

Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral granules of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : January 2011
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Montelukast Sodium Oral Granules
Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited
Drug: Montelukast sodium
Montelukast Sodium Oral Granules 4mg

Active Comparator: SINGULAIR
(Montelukast sodium) Oral Granules 4mg of Merck Sharp & Dohme Ltd., USA
Drug: Montelukast sodium
Montelukast Sodium Oral Granules 4mg

Primary Outcome Measures :
  1. Area under curve(AUC) [ Time Frame: 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. ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects must fulfill the following criteria to be considered for inclusion into this study.

  • 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.
  • No Participation in any clinical study within the past 90 days.
  • No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations vitamins and natural products used for therapeutic benefits), within two weeks prior to study check-in.
  • No history of dehydration from dialThea, vomiting or any other reason within a period of24.0 hours prior to study check-in.
  • No family history of neurological disorders. Not consumed alcohol and xanthine containing food and beverages (chocolates, tea, coffee or cola drink:s), cigarettes and tobacco products, for at least 48.0 hours prior to study check-in.
  • Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Ca1U1abinoids and Barbiturates) in urine during the day of study check-in.
  • Not consumed grapefruit (mosumbi/sweet lime) juice within the 48.0 hours prior to study check-in.
  • Negative alcohol breath analysis during the study check-in.
  • Female volunteers demonstrating a negative pregnancy test.
  • If study volunteer is a female volunteer and is 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.

or is postmenopausal for at least 1 year. or is surgically . sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study volunteer).

Exclusion Criteria The subjects were excluded based on the following criteria.

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01691456

AXIS Clinicals Limited,
Hyderabad, Andhra Pradesh, India, 500 049
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: A. Jayachandra Reddy, Dr. AXIS Clinicals Limited

Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01691456     History of Changes
Other Study ID Numbers: 539-10
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action