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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

NCT01514019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-06-20

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Acebutolol

Acebutolol

DRUG

Placebo

Placebo capsule(Capsules filled up with lactose)

Sponsors & Collaborators

  • Oita University

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Kyushu University

    collaborator OTHER

  • In-Jin Jang, MD, PhD

    lead OTHER

Principal Investigators

  • Kyoichi Ohashi, MD, PhD · Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514019 on ClinicalTrials.gov