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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Acebutolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acebutolol<br>Acebutolol 200 mg capsule (Acetanol®) | Drug: Acebutolol<br>* Acebutolol<br>* Other names: Acebutolol 200 mg capsule (Acetanol®);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule(Capsules filled up with lactose)<br>* Other names: Placebo capsule(Capsules filled up with lactose);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of acebutolol 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. | 0-24 hr after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes | Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate. | 0-24 hr after drug admnistration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLCO2B1 genotype, effect of apple juice