The Population Pharmacokinetics of Montelukast in Infants and Children

Population Pharmacokinetics of Montelukast in Infants and Children

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03238560

Enrollment

100

Registered

2017-08-03

Start date

2016-10-01

Completion date

2018-06-01

Last updated

2017-08-03

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

Conditions

Asthma

Brief summary

The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.

Interventions

DRUGMontelukast Chewable Tablet

Montelukast treatment was used at a dosage of 5mg/day once daily

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Years

Healthy volunteers

Inclusion criteria

* patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.

Exclusion criteria

* expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame	Description
plasma concentration	3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration	To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.
bronchoalveolar lavage fluid(BALF)	Procedure (When the patient underwent fiberoptic bronchoscopy)	To detect the concentrations of montelukast in bronchoalveolar lavage fluid

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

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