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The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Active Comparator |
| |
| Rifampin plus rosuvastatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 20mg po x1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area-under-the-concentration curve (AUC) of rosuvastatin | Blood samples collected over a 48 hour period |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of rosuvastatin | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose | |
| Time to concentration maximum (Tmax) of rosuvastatin | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 32, and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Z Benet, PhD | University of California, San Francisco | Principal Investigator |
| Lynda Frassetto, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTSI Clinical Research Center, UCSF | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin plus rifampin | Drug | Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1 |
|
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |