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

QDose

Status and phase

Unknown

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00426920

IOV/QD001

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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