PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
This study has been completed.
Information provided by:
First received: October 27, 2006
Last updated: May 21, 2013
Last verified: May 2013
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.
Drug: MK0476, montelukast sodium / Duration of Treatment: 14 Days
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 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 3 to 6 months.
|Study Start Date:||June 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
Contacts and Locations