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

Condition(s) targeted: Healthy

Intervention: Atenolol (Drug); Atenolol with apple juice 1200 mL (Drug); Atenolol with apple juice 600 mL (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
In-Jin Jang, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

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.

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AUC of atenolol according to the SLCO2B1 genotypes

Secondary outcome:

Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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

Seoul National University Hospital, Seoul, Korea, Republic of

Starting date: May 2011
Last updated: January 20, 2012