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The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Single dose; Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] | PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞ | Up to Day 115 |
| Maximum observed concentration (Cmax) | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration | Up to Day 115 |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t | Up to Day 115 |
| Time of maximum observed concentration (Tmax) | PK parameter of Acetaminophen: Time of maximum observed concentration | Up to Day 115 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of subjects reporting AEs | Up to Day 115 |
| Apparent volume of distribution (Vz/F) | PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin |
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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 | China |
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| Metformin |
| Drug |
Single dose; Administered orally |
|
| Warfarin | Drug | Single dose; Administered orally |
|
| Atorvastatin | Drug | Single dose; Administered orally |
|
| Digoxin | Drug | Single dose; Administered orally |
|
| HDM1005 injection | Drug | Subcutaneous injection QW |
|
| Up to Day 115 |
| Time of maximum observed concentration (Tmax) | PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin | Up to Day 115 |
| Maximum observed concentration (Cmax) | PK parameter of HDM1005 | Up to Day 115 |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | PK parameter of HDM1005 | Up to Day 115 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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