Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399945
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2006-11-14
Brief Title:
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer Scintigraphy Study
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Phase 1 Single-Dose Open-Label Two-Way Crossover Pharmacoscintigraphy Study of Aerosol Delivery Characteristics Measured by In Vivo Lung Deposition Nebulization Time Serum Tobramycin Concentrations and Pharmacokinetic Parameters and Safety of Tobramycin Administered for Inhalation by PARI eFlow Rapid Electronic Nebulizer No Compressor vs PARI LC PLUS TM Jet Nebulizer With Compressor in Healthy Subjects and in Subjects With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2007-05
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:
This study assesses the aerosol delivery characteristics measured by in vivo lung deposition nebulization time serum tobramycin concentrations and pharmacokinetic parameters and safety of tobramycin inhalation solution administered for inhalation by PARI eFlow rapid electronic nebulizer no compressor vs PARI LC PLUS Jet Nebulizer with compressor in healthy subjects and in subjects with cystic fibrosis
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