None listed
Conditions
Interventions
>6 a 12 a
A single oral dose of 4 mg (and / or 2 or 6 mg) of montelukast will be administered in granules with 1 tablespoon of applesauce.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is male or female and has between> 6 and 3 discrete episodes of wheezing after 8 weeks of age with episodes separated by a symptom-free interval of at least 7 days).
Exclusion criteria
Exclusion criteria: • The patient has a history of any of the following medical conditions: Cystic fibrosis, Tuberculosis, Aspiration of foreign bodies, Dysplasia, bronchopulmonary, Tracheomalacia, Tracheoesophageal fistula, Gastroesophageal reflux, Pertussis, Congenital heart disease • The patient has a history of a disease that, in the opinion of the researcher, could confuse the results of the study or put the patient at risk with the administration of montelukast. • The patient shows significant or unexplained abnormalities in the physical examination and / or pre-study laboratory safety measurements. • The patient is in a situation (for example, unreliable care) or has a condition that, in the opinion of the investigator, may interfere with optimal participation in the study. • The patient has a history of any clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or suffers from lung disease in addition to asthma. • The patient has extreme or unusual dietary habits. • The patient has a history of some clinically significant adverse experience of a serious nature related to the administration of a drug marketed or under investigation (for example, angioedema, anaphylaxis). • The patient has undergone a surgical procedure or has participated in another clinical trial within 8 weeks prior to the administration of the drug. • The patient has signs and symptoms of an upper respiratory tract infection (URI) or has undergone a URI within the week prior to administration of the drug. • The patient has taken some other medication in addition to the allowed asthma medications (Section LE.2.c) within 14 days prior to the administration of the drug. • The patient has used aztemizol within the previous 3 months, or terfenadine, loratadine and / or oral or parenteral corticosteroids within 10 days prior to administration of the drug. • The patient has used theophylline within 10 days prior to the administration of the drug. • The patient has used an oral p-agonist within 24 hours prior to the administration of the montelukast dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Blood samples will be taken for the determination of the estimated AUCpop, Cmax, Tmax C24 hr and the apparent elimination of ti / 2. Samples will be tested by high performance liquid chromatography (lower limit of detection = 3 mg / mL). Measure:Pharmacokinetic Parameters Timepoints:Before and after administration of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Record of adverse events in the report of Cases of Adverse Experiences Measure:Safety Timepoints:At the time of the appearance of events. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed