Recruitment

Recruitment Status
Completed
Estimated Enrollment
32

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Description

Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study...

Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to determine the insulin dose proportionality/linearity of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of the following doses using the Gen2C inhaler: 10 U (one 10 U cartridge) 30 U (one 10 U and one 20 U cartridge) 60 U (three 20 U cartridges) 80 U (four 20 U cartridges)

Tracking Information

NCT #
NCT01490762
Collaborators
Not Provided
Investigators
Study Chair: Chief Medical Officer Mannkind Corporation