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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmaero ApS
• Treatments: Tobramycin

Criteria

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