Pharmacokinetic Study in Healthy Volunteers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
Full description
Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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