Viewing Study NCT00394069



Ignite Creation Date: 2024-05-05 @ 5:07 PM
Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00394069
Status: COMPLETED
Last Update Posted: 2022-02-02
First Post: 2006-10-27

Brief Title: PK Study in 3- to 6- Month-Old Children 0476-268COMPLETED
Sponsor: Organon and Co
Organization: Organon and Co

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: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
2006_545 None None None