Healthy
Conditions
Keywords
SLCO2B1 genotype, effect of apple juice
Brief summary
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C\>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
Interventions
DRUGAcebutolol
Acebutolol
DRUGPlacebo
Placebo capsule(Capsules filled up with lactose)
Sponsors
Oita University
Seoul National University Hospital
Kyushu University
In-Jin Jang, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
Exclusion criteria
* A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of acebutolol according to the SLCO2B1 genotypes | 0-24 hr after drug administration | The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes | 0-24 hr after drug admnistration | Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate. |
Countries
Japan, South Korea
Outcome results
None listed