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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: 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 water CONDITION: Healthy volunteers PRIMARY OUTCOME: 1) Pharmacokinetic parameters of acebutolol; 2) Blood pressure and pulse rate SECONDARY OUTCOME: Adverse drug reactions 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
Epistemonikos ID: 1ad8fa53f678ef45e185393070491e161010ae78
First added on: Aug 22, 2024