Trials / Completed
CompletedNCT00394069
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 3 Months – 6 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-0476, montelukast sodium | Duration of Treatment: 14 Days |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2003-12-01
- Completion
- 2003-12-01
- First posted
- 2006-10-31
- Last updated
- 2024-08-14
Source: ClinicalTrials.gov record NCT00394069. Inclusion in this directory is not an endorsement.