This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days
Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.
Novo Nordisk Investigational Site
Berlin, Germany
Area under the metformin plasma concentration-time curve
Time frame: During a dosing interval (0 to12 hours) at steady state
Area under the digoxin plasma concentration-time curve
Time frame: From time 0 to infinity after single dose
Maximum observed metformin plasma concentration
Time frame: During a dosing interval (0 to 12 hours) at steady state
Maximum observed digoxin plasma concentration
Time frame: 0 to 120 hours after single dose
Maximum observed semaglutide plasma concentration
Time frame: During a dosing interval (0 to 24 hours) at steady state
Area under the SNAC plasma concentration-time curve
Time frame: During a dosing interval (0 to 24 hours) at steady state
Number of hypoglycaemic episodes
Time frame: From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122)
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Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin.