This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.
This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
34
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Group A: Plasma Cmax of digoxin
when given in combination with supaglutide in healthy volunteers
Time frame: 39 Days
Group A: Plasma AUC0-last of digoxin
when given in combination with suplaglutide in healthy volunteers
Time frame: 39 Days
Group A: Plasma AUC0-inf of digoxin
when given in combination with supaglutide in healthy volunteers
Time frame: 39 Days
Group B: Plasma Cmax,ss of Metformin
when given in combination with supaglutide in healthy volunteers
Time frame: 34 Days
Group B: Plasma AUC0-tau of Metformin
when given in combination with suplaglutide in healthy volunteers
Time frame: 34 Days
Group A: Plasma Tmax of Digoxin
when given in combination with supaglutide in healthy volunteers
Time frame: 39 Days
Group A: Plasma t1/2 of digoxin
when given in combination with supaglutide in healthy volunteers
Time frame: 39 Days
Group A: Plasma CL/F of digoxin
when given in combination with suplaglutide in healthy volunteers
Time frame: 39 Days
Group A: Plasma Vz/F of digoxin
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when given in combination with supaglutide in healthy volunteers
Time frame: 39 Days
Group B: Plasma Tmax of Metformin
when given in combination with supaglutide in healthy volunteers
Time frame: 34 Days
Group B: Plasma Cmin,ss of Metformin
when given in combination with suplaglutide in healthy volunteers
Time frame: 34 Days
Group B: Plasma t1/2 of Metformin
when given in combination with suplaglutide in healthy volunteers
Time frame: 34 Days
Group B: Plasma CL/F of Metformin
when given in combination with suplaglutide in healthy volunteers
Time frame: 34 Days
Group B: Plasma Vz/F of metformin
when given in combination with suplaglutide in healthy volunteers
Time frame: 34 Days