Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | February 2007 |
| Contact: | Marcus Hompesch, MD |
| Phone: | 619-427-1300 |
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
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.
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.
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.
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.
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
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