Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.
Organic Anion Transporting Polypeptide1B1 (OATP1B1)
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration|
- pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin [ Time Frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h ] [ Designated as safety issue: No ]
- lipid panel(LDL,HDL,TG,Total cholesterol) [ Time Frame: Day 1 0h, Day 22 0h ] [ Designated as safety issue: No ]
- lipid metabolites [ Time Frame: Day -1 0h, Day21 0h, 4h, 8h ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
20 mg once daily for 21 days
Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.
Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218347
|Korea, Republic of|
|Clinical Trials Center, Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kyung-Sang Yu, MD, PhD||Seoul National University College of Medicine and Hospital|