This trial is conducted in China. The aim of the trial is to investigate the influence of IBI362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin, metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Maximum observed metformin plasma concentration at steady state
Time frame: up to 116 days
Area under the metformin plasma concentration-time curve
Time frame: up to 116 days
Maximum observed warfarin plasma concentration at steady state
Time frame: up to 116 days
Area under the warfarin plasma concentration-time curve
Time frame: up to 116 days
Maximum observed atorvastatin plasma concentration at steady state
Time frame: up to 116 days
Area under the atorvastatin plasma concentration-time curve
Time frame: up to 116 days
Maximum observed digoxin plasma concentration at steady state
Time frame: up to 116 days
Area under the digoxin plasma concentration-time curve
Time frame: up to 116 days
Actual adverse events
Time frame: up to 116 days
Terminal elimination half-life
Time frame: up to 116 days
time to maximum plasma concentration of IBI362
Time frame: up to 116 days
Incremental area under the INR (international normalised ratio) -curve of warfarin
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For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
Time frame: up to 116 days
Total apparent clearance of IBI362
Time frame: up to 116 days
Apparent volume of distribution of IBI362
Time frame: up to 116 days