Healthy
Conditions
Keywords
CYP2C8, genetic polymorphism, rosiglitazone, Korean
Brief summary
The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.
Detailed description
Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8\*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8\*1/\*1 and 2 with CY2C8\*1/\*11.
Interventions
DRUGRosiglitazone
single oral administration of 4mg of rosiglitazone
GENETICCYP2C8 genotype
CYP2C8\*11.
Sponsors
Inje University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer
Exclusion criteria
* Medical problems in taking probe drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 12hr | 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 12hr | 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h |
Outcome results
None listed