NCT00426920UnknownPhase 1
Evaluation of the Pharmacokinetics and Pharmacodynamics of Spray-Dried Recombinant Human Insulin Powder for Inhalation Administered Via a Dry Powder Inhalation Device Relative to SC Recombinant Human Insulin in Healthy Male Volunteers
QDose Limited2 sites in 1 country14 target enrollmentStarted: February 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- early T50%
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
early T50%
maximum insulin serum concentration
late T50%
Tmax
AUC
Secondary Outcomes
- AUC
- early T50%
- late T50%
- Tmax
- maximum glucose infusion rate
Investigators
Study Sites (2)
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