Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00426920
- Lead Sponsor
- QDose Limited
- Brief 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.
- Detailed Description
Explorative, single-center, randomized, open label, 4-way crossover study to evaluate 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method late T50% early T50% maximum insulin serum concentration Tmax AUC
- Secondary Outcome Measures
Name Time Method AUC early T50% late T50% Tmax maximum glucose infusion rate
Trial Locations
- Locations (1)
Profil Institute for Clinical Research Incorporated
🇺🇸Chula Vista, California, United States