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Clinical Trial Details

Trial ID: L6517
Source ID: NCT03638778
Associated Drug: Semaglutide 3 Mg
Title: Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide 3 mg|DRUG: Semaglutide 7 mg|DRUG: Semaglutide B 3 mg|DRUG: Semaglutide B 7 mg|DRUG: Semaglutide C 3 mg|DRUG: Semaglutide C 7 mg|DRUG: Semaglutide D 3 mg|DRUG: Semaglutide D 7 mg
Outcome Measures: Primary: AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing, Calculated based on semaglutide measured in blood., 0 to 24 hours on day 10 | Secondary: Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing, Calculated based on semaglutide measured in blood., 0 to 24 hours on day 10|tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing, Calculated based on semaglutide measured in blood., 0 to 24 hours on day 10|AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing, Calculated based on semaglutide measured in blood., 0 to 30 minutes on day 10|t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing, Calculated based on semaglutide measured in blood. Measured from the 10th. dosing (on Day 10) and up to 35 days after the 10th. dosing (i.e. Day 45)., Days 10-45|Number of treatment emergent adverse events, Count of events., Days 1-47
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-08-17
Completion Date: 2018-12-05
Results First Posted:
Last Update Posted: 2019-11-14
Locations: Novo Nordisk Investigational Site, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT03638778