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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
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.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 14 |
| Start date | 2003-07 |
| Completion | 2003-12 |
Conditions
- Bronchiolitis
Interventions
- MK-0476, montelukast sodium
Primary outcomes
- To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months. — 14 days