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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01514019
• Date of registration: 17/01/2012
• Prospective Registration: No
• Primary sponsor: In-Jin Jang, MD, PhD
• Public 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
• Scientific 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
• Date of first enrolment: January 2012
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01514019
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Japan, Korea, Republic of

Contacts

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

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Acebutolol

Drug: Placebo

Primary Outcome(s)

AUC of acebutolol according to the SLCO2B1 genotypes [Time Frame: 0-24 hr after drug administration]

Secondary Outcome(s)

Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes [Time Frame: 0-24 hr after drug admnistration]

Secondary ID(s)

2012_Acebutolol

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Seoul National University Hospital

Oita University

Kyushu University