4 results
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
To evaluate the safety and effecacy of the Lung Volume Reduction Coil to improve QOL pulmonary function for emphysema subjects with severe hyperinflation.
To evaluate the safety and effecacy of the Lung Volume Reduction Coil to improve QOL pulmonary function for emphysema subjects with severe hyperinflation.
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…