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The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1893 tablet | Drug | HRS-1893 tablet single dose |
| |
| Verapamil tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose | |
| Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose | |
| Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose | |
| Elimination half-life (T1/2) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Single center, open, single arm, fixed sequence
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| Drug |
Verapamil tablet 80 mg tid |
|
| Apparent oral clearance (CL/F) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Apparent volume of distribution (Vz/F) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Accumulated amount of excretion (Ae) for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Urinary excretion fraction(fe)for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Renal clearance(CLr)for HRS-1893 after single dose | from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose |
| Number of subjects with adverse events and the severity of adverse events | from Day 1 to Day 24 after the first dose |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |