Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean

An Open-label, Single-dose, Three-treatment, Three-period Study to Investigate the Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01445964

Enrollment

Registered

2011-10-04

Start date

2011-05-31

Completion date

2011-12-31

Last updated

2012-01-23

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

Conditions

Healthy

Keywords

SLCO2B1 genotype, effect of apple juice

Brief summary

An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.

Interventions

DRUGAtenolol

Atenolol oral administration

DRUGAtenolol with apple juice 1200 mL

Atenolol oral administration with apple juice 1200 mL

DRUGAtenolol with apple juice 600 mL

Atenolol oral administration with apple juice 600 mL

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

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 (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Design outcomes

Primary

Measure	Time frame	Description
AUC of atenolol according to the SLCO2B1 genotypes	0-48 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 atenolol according to the SLCO2B1 genotypes	0-48 hr after drug admnistration	Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	0-48 hr after drug admnistration	Number of participants with adverse event as a measure of safety and tolerability \*Measure of safety and tolerability: physical examinations, ECG, Laboratory tests (including hematology, chemistry, urinalysis) \- Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline where appropriate.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026