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