Deep lung pulmonary delivery of treprostinil
A technology of treprostinil and lung deposition, applied in the field of lung delivery, can solve the problem of not providing sustained drug release, and achieve the effect of increasing efficacy
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[0073] 9. Research plan
[0074] 9.1 General study design and plan
[0075] This was a single-centre, open-label study using a randomized two-way crossover design. Sixteen healthy adult male subjects participated and received study treatment. After providing written informed consent, each study candidate underwent a pre-study assessment and screening to determine eligibility for participation.
[0076] Subjects were instructed and trained in the proper use of the Nebu-Tec Optineb Nebulizer and the use of the drug-free AERx Essence System.
[0077] On each of the two dosing days, eligible subjects administered either the AERx Essence System or the Nebu-Tec Optineb Nebulizer 99m Administration of Tc-labeled treprostinil sodium. Following the initial study dose, subjects underwent a washout period of approximately 48 hours before completing the second (crossover) study dose.
[0078] Following each study dose, subjects underwent gamma scintigraphy and multiple venous blood s...
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