NCT01902121

Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin 10U + 20U	Inhaled Insulin
DRUG	Technosphere® Insulin 30U	Inhaled Insulin

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-01
• Completion: 2014-08-01
• First posted: 2013-07-18
• Last updated: 2014-12-12

Locations

1 site across 1 country: United States