Status:
COMPLETED
Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles
Lead Sponsor:
Seoul National University Hospital
Conditions:
Organic Anion Transporting Polypeptide1B1 (OATP1B1)
Rosuvastatin
Eligibility:
All Genders
20-50 years
Phase:
PHASE4
Brief Summary
This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administratio...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
- Weight: Over 55 kg, within ±20% of ideal body weight
- Must be reliable and willing to make themselves available during the study period
- Must be willing to give blood sample for genotyping
Exclusion
- History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
- History of a significant surgical resection of gastrointestinal tract except appendectomy
- History or evidence of drug abuse
- Use any medication during the last 14 days period before first dosing
- Hypersensitivity to HMG-CoA reductase inhibitor
- Judged to be inappropriate for the study by the investigator
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01218347
Start Date
October 1 2010
End Date
December 1 2010
Last Update
January 6 2011
Active Locations (1)
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1
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea