| Outcome Measures: |
Primary: AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state, h\*nmol/L, After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 | Secondary: Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state, nmol/L, After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84|tmax,sema,SS, time to maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state, h, After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84|CL/Fsema,SS, total apparent clearance of semaglutide at steady state, L/h, After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84|Ctrough,sema,SS, trough semaglutide plasma concentration at steady state, nmol/L, After the last 3 daily doses of oral semaglutide administration at 3, 7 and 14 mg dose levels on day 27-29, 55-57 and 83-85|t½,sema,SS, terminal half-life of semaglutide at steady state, h, After the last dose of oral semaglutide 14 mg on day 84|Vss/Fsema, apparent volume of distribution of semaglutide at steady state, L, After the last dose of oral semaglutide 14 mg on day 84|MRTsema,SS, mean residence time of semaglutide at steady state, h, After the last dose of oral semaglutide 14 mg on day 84|Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS, Index value, After the last dose of oral semaglutide 14 mg on day 84|Change in body weight from baseline, kg, Day 1, day 85|Change in fasting plasma glucose from baseline, mmol/l, Day 1, day 85|Number of treatment-emergent adverse events, Count, From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)|Number of treatment-emergent hypoglycaemic episodes, Count, From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
|
