Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum insulin serum concentration |  |  | 
| early T50% |  |  | 
| late T50% |  |  | 
| Tmax |  |  | 
| AUC |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum glucose infusion rate |  |  | 
| early T50% |  |  | 
| late T50% |  |  | 
| Tmax |  |  | 
| AUC |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, pharmacodynamics, inhaled, recombinant human insulin