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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Atenolol; Drug: Atenolol with apple juice 1200 mL; Drug: Atenolol with apple juice 600 mL

• Registration Number: NCT01445964
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-29
• Study Start: 2011-05
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-04
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Atenolol with apple juice 1200 mL	SLCO2B1 wild type allele
1	Atenolol with apple juice 600 mL	SLCO2B1 wild type allele
2	Atenolol	SLCO2B1 variant allele
2	Atenolol with apple juice 1200 mL	SLCO2B1 variant allele
2	Atenolol with apple juice 600 mL	SLCO2B1 variant allele
1	Atenolol	SLCO2B1 wild type allele

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of