Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-04 @ 11:12 PM
Study NCT ID:
NCT00394069
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2006-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
Sponsor:
Organon and Co
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2006_545 | None | None | View |