Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function
NCT00626249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2013-12-17
Summary
24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points
Conditions
- Mild Nephropathy
- Moderate Nephropathy
- Diabetes Mellitus
Interventions
- DRUG
-
Technosphere Inhalation Powder
Technosphere Inhalation Powder
Sponsors & Collaborators
-
Mannkind Corporation
lead INDUSTRY
Principal Investigators
-
Anders Boss · Mannkind Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2008-09-30
- Completion
- 2008-10-31
Countries
- United States
Study Locations
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