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The study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1301 Tablets | Drug | HRS-1301 tablets. |
| |
| Rosuvastatin Calcium Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 to time t (AUC0-t) | 0 to anticipated 15 days. | |
| Area under the curve from time 0 to time infinity (AUC0-∞) | 0 to anticipated 15 days. | |
| Maximum concentration (Cmax) | 0 to anticipated 15 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum concentration (Tmax) | 0 to anticipated 15 days. | |
| Half-life (t1/2) | 0 to anticipated 15 days. | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Drug |
Rosuvastatin calcium tablets. |
|
| 0 to anticipated 15 days. |
| Adverse events (AEs) | Baseline up to 19 days. |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |