Status:
COMPLETED
Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™
Lead Sponsor:
Pharmaero ApS
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 deliv...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02207426
Start Date
July 1 2014
End Date
September 1 2014
Last Update
April 10 2017
Active Locations (1)
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1
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS