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A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 20 mg PO | Experimental | Rosuvastatin 20 mg daily for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Open-label, one-sequence, multiple administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour |
| Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour |
| Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin | Pharmacokinetic evaluation | Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| lipid panel (low-density lipoprotein cholesterol in mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour |
| lipid panel (high-density lipoprotein cholesterol in mg/dL) | Pharmacodynamic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Yong Chung | South Korea Seoul National University Bundang Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Day 1 0 hour, Day 11 0 hour, Day 22 0 hour |
| lipid panel (Triglyceride in mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour |
| lipid panel (Total cholesterol in units of mg/dL) | Pharmacodynamic evaluation | Day 1 0 hour, Day 11 0 hour, Day 22 0 hour |
| lipid metabolites | Metabolites evaluation | Day -1 0 hour, Day 21 0 hour |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |