Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers

Inclusion Criteria:

- Men and women aged 18 to 55 years, considered healthy based on screening physical
examination, medical history, clinical chemistry, and urinalysis

- HNVs with a screening blood pressure less than 140/90 mm Hg

- Subjects who have hypertension controlled with up to 1 medication and who have a
blood pressure less than 140/90 mm Hg

- Note: For subjects with blood pressure at or above 140/90 mm Hg; two additional
readings 5 minutes apart are allowed but the last blood pressure reading must be
in range

- Subjects who have hypercholesterolemia controlled with up to 1 medication and
who have a low-density lipoprotein value less than 160 mg/dL

- Good venous access for blood draws

- No smoking in the past 6 months (including cigarettes, cigars, and pipes) and urine
cotinine testing < 100 ng/mL

- Body mass index (BMI) < 32 kg/m2

- Completion of informed consent form

Exclusion Criteria:

- Blood donation (500 mL) within the last 8 weeks

- Fasting blood sugar >100 mg/dL

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

- Allergy to study drug, components of Boost and Boost Plus, or other study material

- Clinically significant active or chronic illness

- History of asthma, COPD, or any other clinically relevant chronic lung disease

- Respiratory tract infection within 4 weeks before screening

- History of drug or alcohol abuse within the past 5 years

- Positive urine drug screen

- Clinically significant screening ECG, physical examination, laboratory test, or vital
sign abnormality

- Exposure to any other investigational drug or device within 30 days before treatment
or within 90 days before treatment for drugs known to modify glucose metabolism

- History of malignancy within the 5 years before screening (other than basal cell
carcinoma)

- History of human immunodeficiency virus (HIV) infection or hepatitis B or C

- Women who are pregnant, lactating, or planning to become pregnant during the clinical
study period

- Women of childbearing potential (premenopausal who have not undergone hysterectomy or
bilateral tubal ligation, or postmenopausal for fewer than 2 years) not practicing
adequate birth control. Adequate birth control is defined as using oral,
percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier)
with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this
clinical study includes experiencing amenorrhea for 2 or more years or being
surgically sterile.

- Any subject who, in the opinion of the PI or a designee, appears not to be qualified
for this study