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OpenTrials
Completed

NCT Number: NCT01445964

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.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atenolol

Drug

Atenolol oral administration

Atenolol with apple juice 1200 mL

Drug

Atenolol oral administration with apple juice 1200 mL

Atenolol with apple juice 600 mL

Drug

Atenolol oral administration with apple juice 600 mL

Primary outcomes

  1. AUC of atenolol according to the SLCO2B1 genotypes

    Time frame: 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 outcomes

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

    Time frame: 0-48 hr after drug admnistration

    Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2011
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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