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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

This study has been completed.
Sponsor:
Collaborators:
Oita University
Seoul National University Hospital
Kyushu University
Information provided by (Responsible Party):
In-Jin Jang, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01514019
First received: January 17, 2012
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Acebutolol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • AUC of acebutolol according to the SLCO2B1 genotypes [ Time Frame: 0-24 hr after drug administration ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes [ Time Frame: 0-24 hr after drug admnistration ] [ Designated as safety issue: Yes ]
    Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate.


Enrollment: 16
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acebutolol
Acebutolol 200 mg capsule (Acetanol®)
 Drug: Acebutolol
Acebutolol
Other Name: Acebutolol 200 mg capsule (Acetanol®)
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule(Capsules filled up with lactose)
Other Name: Placebo capsule(Capsules filled up with lactose)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514019

Locations
Japan
General Clinical Research Center, Oita University Hospital
Oita, Japan
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
In-Jin Jang, MD, PhD
Oita University
Seoul National University Hospital
Kyushu University
Investigators
Study Chair: Kyoichi Ohashi, MD, PhD Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
  More Information

No publications provided

Responsible Party: In-Jin Jang, MD, PhD, Professor of Clinical Pharmacology and Therapeutics, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01514019     History of Changes
Other Study ID Numbers: 2012_Acebutolol
Study First Received: January 17, 2012
Last Updated: June 19, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
SLCO2B1 genotype
effect of apple juice

Additional relevant MeSH terms:
Acebutolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013