Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study

NCT00399945

Cystic Fibrosis

COMPLETED PHASE1

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

NCT00420836

Cystic Fibrosis

COMPLETED PHASE1

A Study of the Clinical Benefit of Tobramycin Inhalation Solution

NCT06106789

Bronchiectasis Cystic Fibrosis Lung Infection

ACTIVE_NOT_RECRUITING

Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

NCT01953367

Cystic Fibrosis

COMPLETED PHASE1

Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)

NCT01844778

Cystic Fibrosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each subject receives tobramycin with 3 different inhalation devices:

* 75 mg tobramycin delivered to the airways via TobrAir® 6.0.
* 300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy® SX.
* 112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI® Podhaler™.

Each dose is separated by a minimum washout of at least 68 h.

Blood samples for PK analysis of tobramycin will be collected at regular time intervals until 24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo scintigraphic assessments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TobrAir® 6.0

Tobramycin 75mg inhalation solution

Group Type EXPERIMENTAL

Tobramycin

Intervention Type DRUG

TOBI® / PARI LC® PLUS Nebulizer

Tobramycin 300mg nebulizer solution

Group Type EXPERIMENTAL

Tobramycin

Intervention Type DRUG

TOBI® Podhaler™

Tobramycin 112mg (4x28mg) inhalation powder

Group Type EXPERIMENTAL

Tobramycin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tobramycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males or non-pregnant, non-lactating healthy females
* Aged 18 to 65 years
* Body mass index of 18.0 to 29.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must provide written informed consent
* Must agree to use an adequate method of contraception

Exclusion Criteria

* Participation in a clinical research study within the previous 3 months
* Subjects who have previously been enrolled in this study
* Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission and be using an appropriate method of contraception)
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* History of chronic respiratory disorders (including asthma) as judged by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes