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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warfarin+atorvastatin+IBI362 | Experimental |
| |
| metformin+digoxin+IBI362 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed metformin plasma concentration at steady state | up to 116 days | |
| Area under the metformin plasma concentration-time curve | up to 116 days | |
| Maximum observed warfarin plasma concentration at steady state | up to 116 days | |
| Area under the warfarin plasma concentration-time curve | up to 116 days | |
| Maximum observed atorvastatin plasma concentration at steady state | up to 116 days | |
| Area under the atorvastatin plasma concentration-time curve | up to 116 days | |
| Maximum observed digoxin plasma concentration at steady state | up to 116 days | |
| Area under the digoxin plasma concentration-time curve | up to 116 days |
| Measure | Description | Time Frame |
|---|---|---|
| Actual adverse events | up to 116 days | |
| Terminal elimination half-life | up to 116 days | |
| time to maximum plasma concentration of IBI362 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerospace Center Hospital | Beijing | Beijing Municipality | 100049 | China |
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| digoxin | Drug | 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. |
|
| IBI362 | Drug | 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. |
|
| warfarin | Drug | 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. |
|
| atorvastatin | Drug | 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. |
|
| up to 116 days |
| Incremental area under the INR (international normalised ratio) -curve of warfarin | up to 116 days |
| Total apparent clearance of IBI362 | up to 116 days |
| Apparent volume of distribution of IBI362 | up to 116 days |
| ID | Term |
|---|---|
| D008687 | Metformin |
| D004077 | Digoxin |
| C000719829 | mazdutide |
| D014859 | Warfarin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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