Skip to main content
OpenTrials
Completed

NCT Number: NCT01218347

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Trials Center, Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Rosuvastatin

Drug

20 mg once daily for 21 days

Primary outcomes

  1. pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin

    Time frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h

Secondary outcomes

  1. lipid panel(LDL,HDL,TG,Total cholesterol)

    Time frame: Day 1 0h, Day 22 0h

  2. lipid metabolites

    Time frame: Day -1 0h, Day21 0h, 4h, 8h

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration

Acronym: OATP

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 11, 2010
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.