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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by QDose Limited.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
QDose Limited
ClinicalTrials.gov Identifier:
NCT00426920
First received: January 24, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 24, 2007
January 24, 2007
February 2007
Not Provided
  • maximum insulin serum concentration
  • early T50%
  • late T50%
  • Tmax
  • AUC
Same as current
No Changes Posted
  • maximum glucose infusion rate
  • early T50%
  • late T50%
  • Tmax
  • AUC
Same as current
Not Provided
Not Provided
 
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Insulin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
14
Not Provided
Not Provided

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
Male
18 Years to 45 Years
Yes
Contact: Marcus Hompesch, MD 619-427-1300
Contact: 24-hour emergency number 619-409-1277
United States
 
NCT00426920
IOV/QD001
Not Provided
Not Provided
QDose Limited
Not Provided
Principal Investigator: Marcus Hompesch, MD Profil Institute for Clinical Research Incorporated
QDose Limited
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP