NCT03238560|UnknownDMCFDA Drug
The Population Pharmacokinetics of Montelukast in Infants and Children
Population Pharmacokinetics of Montelukast in Infants and Children
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Sponsor study identifier
observational
100
1 country
1
Study Start
October 1, 2016
Actual (reported)Primary Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2016
Actual (reported)August 1, 2017
Actual (reported)August 3, 2017
Actual (reported)June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
plasma concentration
To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.
3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration
bronchoalveolar lavage fluid(BALF)
To detect the concentrations of montelukast in bronchoalveolar lavage fluid
Procedure (When the patient underwent fiberoptic bronchoscopy)
Montelukast treatment was used at a dosage of 5mg/day once daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Montelukast Chewable Tablet
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Montelukast Chewable Tablet
Named ingredient: montelukast
View registry recordThe patients are cared in the department of pediatric respiratory at Shandong Provincial Qianfoshan Hospital, Jinan, China.
Contact the study team to confirm eligibility.
Shandong Provincial Qianfoshan Hospital
Ji'nan, Shandong, 250014, China
Wei Zhao, Ph.D
Shandong University
First Submitted
August 1, 2017
First Posted
August 3, 2017
Study Start
October 1, 2016
Actual (reported)Primary Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 3, 2017
Record last verified: 2017-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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