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

Status unconfirmed · Phase 1

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00426920

Run by

QDose Limited

People needed

14

Starts

2007-02-01

Last updated by the study team

2007-01-25

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Profil Institute for Clinical Research Incorporated — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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