Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
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A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary Outcome Measures :
To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 months.
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Layout table for eligibility information
Ages Eligible for Study:
1 Month to 3 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria :
Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.
Exclusion Criteria :
Anemia or history of any significant illness that will pose additional risk to the patient.