Pharmacokinetic Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy

• Body mass index (BMI) < 32 kg/m2

• FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

• Pre-existing asthma or chronic obstructive pulmonary disease (COPD)

• History of coronary artery disease, peripheral vascular disease, or congestive heart failure

• Blood donation within the previous 3 months