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

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 - The effects of the SLCO2B1 polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006918

Enrollment

Registered

2011-12-21

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Placebo - (Wash out period) - Acebutolol with water - (Wash out period) - Acebutolol with apple juice Placebo - (Wash out period) - Acebutolol with apple juice - (Wash out period) - Acebutolol with wa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A subject with body weight between 45 kg (inclusive) and 80 kg (exclusive) for female, and between 50 kg (inclusive) and 90 kg (exclusive) for male, and body mass index (BMI) between 17 (inclusive) and 28 (exclusive) for both gender. 2) Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (including the case that the investigator considers the deviation to be irrelevant for the purpose of the study) 5) A subject who has the*4/*4 genotype of N-acetyltransferase-2

Exclusion criteria

Exclusion criteria: 1) A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies 2) A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory (including asthma and COPD), endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease 3) A subject with a history of surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug 4) A subject whose systolic blood pressure (SBP): < or = 100 mmHg, or > or = 140 mmHg, diastolic blood pressure (DBP): < or = 40 mmHg, or > pr = 90 mmHg, pulse rate (PR): < or =50/min, or > or = 100 /min 5) A subject who has taken any prescribed medication or herbal compounds 6) A subject who has taken any type of fruit or its juice (apple juice, grapefruit juice, orange juice, grape, etc.) within 7 days prior to the study drug administration 7) A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months) 8) A female subject who are pregnant or breast feeding 9) A female subject who does not agree to use routinely adequate contraception

Design outcomes

Primary

Measure	Time frame
1) Pharmacokinetic parameters of acebutolol 2) Blood pressure and pulse rate	—

Secondary

Measure	Time frame
Adverse drug reactions	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactTsutomu Kotegawa

Oita University Faculty of Medicine Department of Clinical Pharmacology and Therapeutics

kotet@oita-u.ac.jp097-586-5952

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C&gt;T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers