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
Recruitment status was Not yet recruiting
Sponsor:
QDose Limited
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Insulin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by QDose Limited:
Primary Outcome Measures:
- maximum insulin serum concentration
- early T50%
- late T50%
- Tmax
- AUC
Secondary Outcome Measures:
- maximum glucose infusion rate
- early T50%
- late T50%
- Tmax
- AUC
| Estimated Enrollment: | 14 |
| Study Start Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426920
Contacts
| Contact: Marcus Hompesch, MD | 619-427-1300 | |
| Contact: 24-hour emergency number | 619-409-1277 |
Locations
| United States, California | |
| Profil Institute for Clinical Research Incorporated | Not yet recruiting |
| Chula Vista, California, United States, 91911 | |
| Contact: Marcus hompesch, MD 619-427-1300 | |
| Contact: 24-hour emergency number 619-409-1277 | |
| Principal Investigator: Marcus Hompesch, MD | |
Sponsors and Collaborators
QDose Limited
Investigators
| Principal Investigator: | Marcus Hompesch, MD | Profil Institute for Clinical Research Incorporated |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00426920 History of Changes |
| Other Study ID Numbers: | IOV/QD001 |
| Study First Received: | January 24, 2007 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by QDose Limited:
|
pharmacokinetics pharmacodynamics inhaled recombinant human insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013