| Trial ID: | L6455 |
| Source ID: | NCT00633997
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| Associated Drug: |
Vildagliptin
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| Title: |
Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10, Baseline (Day -1) to End of Study (Day 17 +/- 2 days) | Secondary: 10 day's treatment with vildagliptin 50 mg orally twice daily on hematology, blood chemistry and physical exams in healthy volunteers and patients with type 2 diabetes, Baseline (Day -1) to End of study (Day 17 +/- 2 days)
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2008-02
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| Completion Date: |
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| Results First Posted: |
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| Last Update Posted: |
2020-12-17
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| Locations: |
Novartis Investigator Site, Baltimore, Maryland, 21225, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00633997
|