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Clinical Trial Details

Trial ID: L6455
Source ID: NCT00633997
Associated Drug: Vildagliptin
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
Acronym:
Status: TERMINATED
Study Results: NO
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
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2008-02
Completion Date:
Results First Posted:
Last Update Posted: 2020-12-17
Locations: Novartis Investigator Site, Baltimore, Maryland, 21225, United States
URL: https://clinicaltrials.gov/show/NCT00633997