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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01691456
First received: September 20, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  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: 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. ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast Sodium Oral Granules
Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited
Drug: Montelukast sodium
Montelukast Sodium Oral Granules 4mg
Other Name: SINGULAIR
Active Comparator: SINGULAIR
(Montelukast sodium) Oral Granules 4mg of Merck Sharp & Dohme Ltd., USA
Drug: Montelukast sodium
Montelukast Sodium Oral Granules 4mg
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691456

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

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01691456     History of Changes
Other Study ID Numbers: 539-10
Study First Received: September 20, 2012
Last Updated: September 20, 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 July 22, 2014