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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Atenolol with apple juice 1200 mL; Drug: Atenolol; Drug: Atenolol with apple juice 600 mL

Study type: Interventional

Funder types: Other

Identifiers

NCT01445964

SNUCPT11_ATE

Pan Asian-Atenolol-1

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1

Experimental group

Description:

SLCO2B1 wild type allele

Treatment:

Drug: Atenolol

Drug: Atenolol with apple juice 1200 mL

Drug: Atenolol with apple juice 600 mL

2

Experimental group

Description:

SLCO2B1 variant allele

Treatment:

Drug: Atenolol

Drug: Atenolol with apple juice 1200 mL

Drug: Atenolol with apple juice 600 mL