drugset / Trial / NCT01490762

Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler

NCT01490762

Phase 1 Completed 35 enrolled Mannkind Corporation
RandomizedCrossoverOpen-labelBasic science

Summary

This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.

Timeline

Start
2011-12
Primary completion
2012-05
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic 10 iu Inhaled
Comparator Insulin Protein / enzyme biologic 15 iu Subcutaneous
Comparator Insulin Protein / enzyme biologic 30 iu Inhaled
Comparator Insulin Protein / enzyme biologic 60 iu Inhaled
Comparator Insulin Protein / enzyme biologic 80 iu Inhaled

Indications

No indication recorded.