Hypercholesterolemia Clinical Trial
Official title:
Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia
The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia patients.
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the
participation of this study by their written consent will undergo screening, including
physical examination and clinical laboratory test etc, to evaluate whether they are eligible
to participate in this study. Study drugs will be administered at about 9 A.M. in the
morning of the first drug administration day, after blood collection for evaluation of
pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and
genetic analyses.
Subjects should take the investigational product by themselves every morning for 8 weeks. On
the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics,
lipid profiles, metabolomics and urine collection for metabolomics will be conducted by
visiting the clinical trials center. On the days of 2nd, 4th and 6th week, the study drug
will be taken after blood and urine collection.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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