Pharmacokinetic Study in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01365117

Run by

Mannkind Corporation

People needed

50

Starts

2011-01-01

Expected to finish

2011-04-01

Last updated by the study team

2012-06-14

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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