Status:
COMPLETED
A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers
Lead Sponsor:
Mannkind Corporation
Conditions:
Diabetes Mellitus
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will investigate the effects of inhaled albuterol \& fluticasone on one dose of TI Inhalation Powder. A total of 12 eligible subjects will be enrolled.
Eligibility Criteria
Inclusion
- Subjects must have a fasting blood glucose (BG) level of less than 6.1 mmol/L FEV1/ FVC = LLN TLC = 80% Predicted DLco (unc) = 80% Predicted (Miller) No significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of = 12% and = 200 mL in FEV1 or FVC) at Screening FEV1 = 80% (NHANES III Predicted
Exclusion
- History of diabetes mellitus Previous exposure to any inhaled insulin product Any known pulmonary disease or inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 Major organ system diseases including seizures, heart failure, uncontrolled hypertension, aneurysm, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00674050
Start Date
May 1 2008
End Date
October 1 2008
Last Update
June 13 2012
Active Locations (1)
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1
ICON Development Solutions
Manchester, United Kingdom, United Kingdom