Pharmacogenomic Research in Korean Population

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001119

Enrollment

Registered

2014-05-26

Start date

2013-09-09

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The study consists of two interventions Intervention 1: Afetr an overnight fast, all subjects take a single oral dose of 40 mg simvastatin with 240 mL water, and have 7 mL of their blood sampl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Individuals with the aforementioned 4 different SLCO1B1 and ABCB1 genotypes confirmed by pre-genotyping 2.Non-smoker,non-heavy drinker 3.Not administration of other drugs 4.Healthy volunteers confirmed by physical and laboratory examination 5.Informed consent provided

Exclusion criteria

Exclusion criteria: 1.Individuals with other than the aforementioned 4 different SLCO1B1 and ABCB1 genotypes confirmed by pre-genotyping 2.Smoker or heavy drinker 3.Coadministration of other drugs 4.Not healthy from laboratory or physical examination 5.Informed consent not provided

Design outcomes

Primary

Measure	Time frame
simvastatin, simvastatin acid plasma concentration	—

Secondary

Measure	Time frame
simvastatin, simvastatin acid pharmacokinetic parameters (AUC, Cmax, T1/2, etc)	—

Countries

Korea, Republic of

Contacts

Public ContactHan-Sung

National Institute of Food and Drug Safety Evaluation

Outcome results