This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Tablet given orally
Tablet given orally
Tablet given orally
Novo Nordisk Investigational Site
Berlin, Brandenburg, Germany
Parexel International GmbH
Berlin, Germany
AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
measured in h\*nmol/L
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
measured inh\*ng/mL
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2
Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)
measured in nmol/L
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
measured in ng/mL
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2
tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state
measured in hours
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
measured in hours
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2
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