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

General Clinical Research Center, Oita University Hospital0 个研究点目标入组 16 人开始时间: 2011年12月21日最近更新: 2023年10月17日

适应症

试验速览

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•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

发起方

General Clinical Research Center, Oita University Hospital