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Completed

NCT Number: NCT01514019

An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers

An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Clinical Research Center, Oita University Hospital, Ōita, Japan

Loading trial locations.

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 (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Treatment and study plan

Acebutolol

Drug

Acebutolol

Other names: Acebutolol 200 mg capsule (Acetanol®)

Placebo

Drug

Placebo capsule(Capsules filled up with lactose)

Other names: Placebo capsule(Capsules filled up with lactose)

Primary outcomes

  1. AUC of acebutolol according to the SLCO2B1 genotypes

    Time frame: 0-24 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 acebutolol according to the SLCO2B1 genotypes

    Time frame: 0-24 hr after drug admnistration

    Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate.

Sponsors and collaborators

Lead sponsor

In-Jin Jang, MD, PhD

Other

Collaborators

  • Kyushu University
  • Oita University
  • Seoul National University Hospital

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2012
Registry last updated
Jun 20, 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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