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

NCT01445964 | Completed Phase 4

• 2 other identifiers: SNUCPT11_ATEPan Asian-Atenolol-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

SLCO2B1 genotype; effect of apple juice

Outcome Measures

Primary Outcomes (1)

• AUC of atenolol according to the SLCO2B1 genotypes

  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.

  0-48 hr after drug administration

Secondary Outcomes (2)

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

  0-48 hr after drug admnistration

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

  0-48 hr after drug admnistration

Study Arms (2)

1

EXPERIMENTAL

SLCO2B1 wild type allele

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

2

EXPERIMENTAL

SLCO2B1 variant allele

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

Interventions

Atenolol DRUG

Atenolol oral administration

1; 2

Atenolol with apple juice 1200 mL DRUG

Atenolol oral administration with apple juice 1200 mL

1; 2

Atenolol with apple juice 600 mL DRUG

Atenolol oral administration with apple juice 600 mL

1; 2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Atenolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• In-Jin Jang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology and Therapeutics

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: October 4, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

KR (1)