Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions

Study Overview
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Brief Summary
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Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5 mg tablet. Dosing periods were separated by a washout period during fasted study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Official Title
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An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets 5mg [Reference Formulation, Merck & Co., Inc. USA] in Healthy Human Volunteers Under Fasting Conditions.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Torrent's Montelukast Sodium Chewable Tablets 5mg
* Drug: Singulair® (Montelukast Sodium) Chewable Tablets 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The volunteers were included in the study based on the following criteria: Sex: male. Age: 18 - 45 years. Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. Healthy and willing to participate in the study. Volunteer willing to adhere to the protocol requirements and to provide written informed consent. Non-smokers or smoker who smokes less than 10 cigarettes per day Exclusion Criteria: The volunteers were excluded from the study based on the following criteria: Clinically relevant abnormalities in the results of the laboratory screening evaluation. Clinically significant abnormal ECG or Chest X-ray. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P. Respiratory rate less than 12/minute or more than 20/minute History of allergy to the test drug or any drug chemically similar to the drug under investigation. History of alcohol or drug abuse Positive breath alcohol test Recent history of kidney or liver dysfunction. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study. Volunteers suffering from any chronic illness such as arthritis, asthma etc. History of heart failure. HIV, HCV, HBsAg positive volunteers. Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test. Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. Administration of any study drug in the period 0 to 3 months before entry to the study. History of significant blood loss due to any reason, including blood donation in the past 3 months. History of pre-existing bleeding disorder. Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Torrent's Montelukast Sodium Chewable Tablets 5mg|nan|
|Drug: Singulair® (Montelukast Sodium) Chewable Tablets 5mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence based on Composite of Pharmacokinetics | bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax. | plasma samples were obtained from blood drawn at Pre-dose and 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 14.00 and 24.00 hours after dose administration. |