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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Compare the maximum plasma concentration (Cmax)
Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment.
Time frame: 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.
Time frame: vancomycin PO will administered for 7 days
Explore the gut microbiome species change
Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days
Time frame: vancomycin PO will administered for 7 days
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