Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
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|ClinicalTrials.gov Identifier: NCT01466608|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: Rosuvastatin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||August 2013|
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
Oral administration of rosuvastatin 20 mg once daily for 21 days.
Other Name: Crestor Tablet 20 mg manufactured by Astrazeneca
- Changes of serum lipid levels from baseline for 8 weeks [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57 ]Changes of serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglyceride levels at fasting from baseline to Day 1, Day 15, Day 29, Day 43, Day 57
- Urinary and plasma levels of the lipid metabolites for 8 weeks [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57 ]The levels of the lipid metabolites in the samples collected prior to daily rosuvastatin dose on Day 1, Day 15, Day 29, Day 43, Day57 using UPLS-TOF-MS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466608
|Korea, Republic of|
|Clinical Trials Center, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-799|
|Principal Investigator:||Young Min Cho, MD, PhD||Seoul National University Hospital|