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Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

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Last updated:31st Aug 2013

This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.

Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
Enrollment: 72
Study Start Date: September 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

- Experimental:
Vantobra; Treatment A
Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution
- Active Comparator: TOBI; Treatment B
TOBI, 300 mg tobramycin/5 mL nebulizer solution

Category Value
Study start date 2013-09-01

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