Overview

Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
QDose Limited
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- male

- non smoking for at least 12 months

- BMI equal to or less than 28

- no clinically significant abnormalities

- FVC and FEV1 equal to or more than 80%

- willing to participate and to sign informed consent form

Exclusion Criteria:

- positive results for insulin antibodies at screening

- history of substance abuse or dependency within last 5 years

- positive screening test for substance abuse

- positive blood test for HIV, hepatitis B or hepatitis C antibody

- fasting blood glucose of more than 126mg/dl

- any existing medical conditions which might interfere with absoprtion, distribution,
metabolism or excretion of study medication

- history of bronchospastic disease(asthma), tachycardia, migraine headache,
hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe
hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved
psychiatric illness, drug-induced myopathy or any other clinically significant
abnormality

- has received investigational medications within 21 days prior to receiving the first
dose of study medication

- has taken or used any prescription medications within 21 days prior to receiving the
first dose of study medication

- has taken or used any OTC medications,vitamins or herbal and/or nutritional
supplements within 10 days days prior to receiving the first dose of study medication

- health that may be adversely affected by procedures or medications used in the study

- unwillingness or inability to understand or to follow required study restrictions and
procedures