Clinical trial
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
NCT00394069 · Organon and Co, Industry · Completed
Key facts
| NCT number | NCT00394069 |
|---|---|
| Title | PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED) |
| 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 |
| Lead sponsor | Organon and Co, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Bronchiolitis |
| Intervention type | Drug |
| Interventions | MK-0476, montelukast sodium |
| Enrollment | 14 |
| Start date | Jul 1, 2003 |
| Primary completion | Dec 1, 2003 |
| Completion | Dec 1, 2003 |
| First posted | Oct 31, 2006 |
| Last update posted | Aug 14, 2024 |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: