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The purpose of this study is to evaluate the influence of HRS9531 injection on gastric emptying and pharmacokinetics of metformin, atorvastatin, warfarin, and digoxin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the acetaminophen plasma concentration-time curve | From time 0 to 24 hours after a single dose. | |
| Maximum observed acetaminophen concentration | From time 0 to 24 hours after a single dose. | |
| Time of maximum observed acetaminophen concentration | From time 0 to 24 hours after a single dose. | |
| Area under the metformin plasma concentration-time curve | From time 0 to 12 hours after the last of 7 repeated doses. | |
| Area under the S-warfarin plasma concentration-time curve | From time 0 to 168 hours after a single dose. | |
| Area under the atorvastatin plasma concentration-time curve | From time 0 to 72 hours after a single dose. | |
| Area under the digoxin plasma concentration-time curve | From time 0 to 120 hours after a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve of acetaminophen from 0 to infinity | Start of treatment up to 168 hours. | |
| Apparent volume of distribution of acetaminophen | Start of treatment up to 168 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
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| Drug |
Metformin |
|
| Warfarin | Drug | Warfarin |
|
| Atorvastatin | Drug | Atorvastatin |
|
| Digoxin | Drug | Digoxin |
|
| HRS9531 | Drug | HRS9531 |
|
| Time of maximum observed metformin concentration after 3.5 days of treatment | Start of Treatment up to 30 hours. |
| Clearance of metformin after 3.5 days of treatment | Start of Treatment up to 30 hours. |
| Apparent volume of distribution of metformin after 3.5 days of treatment | Start of Treatment up to 30 hours. |
| Time of maximum observed S-warfarin concentration | Start of Treatment up to 168 hours. |
| Clearance of S-warfarin | Start of Treatment up to 168 hours. |
| Apparent volume of distribution of S-warfarin | Start of Treatment up to 168 hours. |
| Time of maximum observed atorvastatin (and its active metabolites) concentration | Start of Treatment up to 72 hours. |
| Clearance of atorvastatin (and its active metabolites) | Start of Treatment up to 72 hours. |
| Time of maximum observed digoxin concentration | Start of Treatment up to 120 hours. |
| Maximum observed digoxin concentration | Start of Treatment up to 120 hours. |
| Clearance of digoxin | Start of Treatment up to 120 hours. |
| Apparent volume of distribution of digoxin | Start of Treatment up to 120 hours. |
| Time of maximum observed HRS9532 concentration | Start of Treatment up to 168 hours. |
| Maximum observed HRS9531 concentration | Start of Treatment up to 168 hours. |
| Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration | Start of Treatment up to 168 hours. |
| Area under the concentration versus time curve of HRS9531 from 0 to infinity | Start of Treatment up to 168 hours. |
| Incidence and severity of adverse events | Screening period up to 117 days. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D008687 | Metformin |
| D014859 | Warfarin |
| D000069059 | Atorvastatin |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| 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 |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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