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The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm | Experimental | Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Administered orally |
| |
| Empagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] | PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞ | through study completion, an average of 11 weeks |
| Cmax | PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration | through study completion, an average of 11 weeks |
| AUC[0-t] | PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour | through study completion, an average of 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of HDM1002 | PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc | through study completion, an average of 11 weeks |
| other PK parameters | Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc |
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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 | Recruiting | Hefei | China |
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| Drug |
Single dose; Administered orally |
|
| Midazolam | Drug | Single dose; Administered orally |
|
| Valsartan | Drug | Single dose; Administered orally |
|
| Warfarin | Drug | Single dose; Administered orally |
|
| HDM1002 | Drug | Administered orally |
|
| through study completion, an average of 11 weeks |
| Adverse events (AEs) | Number of subjects reporting AEs | through study completion, an average of 11 weeks |
| ID | Term |
|---|---|
| D008687 | Metformin |
| C570240 | empagliflozin |
| D008874 | Midazolam |
| D000068756 | Valsartan |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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