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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00399945 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Tobramycin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All subjects:
Healthy Subjects:
Subjects with Cystic Fibrosis:
Exclusion Criteria:
All subjects:
Healthy Subjects:
Subjects with Cystic Fibrosis:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00399945 History of Changes |
| Other Study ID Numbers: | CTBM100B2202 |
| Study First Received: | November 14, 2006 |
| Last Updated: | May 4, 2007 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacoscintigraphy |
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Pathologic Processes Tobramycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |