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This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group | Experimental | Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin 250Mg Capsule | Drug | Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the maximum plasma concentration (Cmax) | Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment. | vancomycin PO will administered for 7 days |
| Compare the area under the time-plasma concentration curve (AUC) | Compare the area under the time-plasma concentration curve (AUC) of simvastatin before and after vancomycin PO treatment. | vancomycin PO will administered for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the gut microbiome species change | Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days | vancomycin PO will administered for 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | 03080 | South Korea |
Investigators have no plan to share individual participant data.
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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