PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

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 3 to 6 Months

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00394069

Enrollment

Registered

2006-10-31

Start date

2003-07-31

Completion date

2003-12-31

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Brief summary

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.

Interventions

DRUGMK-0476, montelukast sodium

Duration of Treatment: 14 Days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Months to 6 Months

Healthy volunteers

Inclusion criteria

: * Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms

Exclusion criteria

: * A history of any significant illness that will pose additional risk to the patient

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.	14 days

Secondary

Measure	Time frame
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 3 to 6 months.	24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026