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

A Phase 1 Study in Healthy Volunteers Investigating the Delivery of Tobramycin Using the TobrAir® 6.0 Device Compared With the Delivery of Marketed Tobramycin Nebuliser Solution (TOBI®) by PARI LC® PLUS and PARI TurboBoy® SX and With Delivery of Tobramycin by the TOBI® Podhaler™ Device, Using Pharmacokinetic and Pharmacoscintigraphic Methods.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02207426

Enrollment

Registered

2014-08-04

Start date

2014-07-31

Completion date

2014-09-30

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

Brief summary

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.

Detailed description

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.

Interventions

DRUGTobramycin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bioavailability of tobramycin	3 days	Bioavailability of tobramycin

Secondary

Measure	Time frame	Description
Scintigraphic measurement of lung deposition of radiolabelled tobramycin	1 day	Scintigraphic measurement of lung deposition of radiolabelled tobramycin

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026