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Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | rosuvastatin alone and then in combination with hetrombopag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | 0-72 hours post dose | |
| Area Under the plasma concentration vs time curve (AUC0-72) | 0-72 hours post dose | |
| Area under the blood concentration vs time curve (AUC0-inf) | 0-infinity |
| Measure | Description | Time Frame |
|---|---|---|
| Other pharmacokinetics parameters of rosuvastatin | Tmax | 0-72 hours post dose |
| The number of volunteers with adverse events as a measure of safety and tolerability | up to Day 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueying Ding | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xueying General Ding | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000614661 | hetrombopag |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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rosuvastatin alone and then in combination with hetrombopag
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| Hetrombopag | Drug | 7.5 mg hetrombopag was administered on Day 6 to Day 11. |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |