Overview
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
QDose LimitedTreatments:
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