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Trial record 62 of 1420 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT01674504
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
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 chewable tablets 4 mg and 5 mg Phase 1

Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium) chewable tablets 4mg and 5 mg of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 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 2010
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Montelukast sodium
Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited
Drug: Montelukast sodium chewable tablets 4 mg and 5 mg
Montelukast sodium chewable tablets 4mg and 5mg
Other Name: SINGTJLAIR ®

Active Comparator: SINGTJLAIR ®
SINGTJLAIR ® (containing Montelukast sodium)chewable tablets 5mg of Merck Sharp & Dohme Ltd., USA
Drug: Montelukast sodium chewable tablets 4 mg and 5 mg
Montelukast sodium chewable tablets 4mg and 5mg
Other Name: SINGTJLAIR ®




Primary Outcome Measures :
  1. Area under curve(AUC) [ Time Frame: Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 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)

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.
  • Prevalence of oral candidiasis, aphthous ulcer or other oral lesions.
  • Difficulty in swallowing tablets/capsules.
  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01674504


Locations
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India
Bioserve Clinical Research Private Limited
Balanagar, Hyderabad, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dwarakanath A, Dr. Bioserve Clinical Research Private Limited,

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01674504     History of Changes
Other Study ID Numbers: 741/09
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012
Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Montelukast Sodium
crossover
Additional relevant MeSH terms:
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Montelukast
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