Status:
UNKNOWN
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
Lead Sponsor:
QDose Limited
Conditions:
Diabetes Mellitus
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00426920
Start Date
February 1 2007
Last Update
January 25 2007
Active Locations (1)
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1
Profil Institute for Clinical Research Incorporated
Chula Vista, California, United States, 91911