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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Acebutolol; Drug: Placebo

• Registration Number: NCT01514019
• Lead Sponsor: In-Jin Jang, MD, PhD

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acebutolol	Acebutolol	Acebutolol 200 mg capsule (Acetanol®)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
AUC of acebutolol according to the SLCO2B1 genotypes	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 Outcome Measures

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

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

General Clinical Research Center, Oita University Hospital; 🇯🇵 Oita, Japan