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This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1893 tablet A and HRS-1893 tablet B Group | Experimental |
| |
| HRS-1893 tablet B Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1893 tablet A | Drug | Specified dose on specified days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. | |
| Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak concentration (Tmax) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. | |
| Elimination half-life (t1/2) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| HRS-1893 tablet B |
| Drug |
Specified dose on specified days. |
|
| Apparent clearance (CL/F) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. |
| Apparent volume of distribution (Vz/F) | From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2. |
| The incidence and severity of any adverse events (AEs) | From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2. |