An Open-label, Three-period, One-sequence Crossover Clinical Trial to Evaluate the Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

Seoul National University Hospital1 个研究点分布在 1 个国家目标入组 13 人开始时间: 2021年7月13日最近更新: 2021年9月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Seoul National University Hospital
入组人数: 13
试验地点: 1
主要终点: CL/F of itraconazole

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.

详细描述

Evaluation criteria

Pharmacokinetic assessment with plasma concentrations of itraconazole and hydroxy-itraconazole
Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, and laboratory tests

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 19 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy adult aged ≥ 19 years and ≤ 50 years at the time of screening
•Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2 at the time of screening
•A subject without any congenital or chronic disease, and has no medical examination result as pathological symptoms or signs
•A subject who listened to sufficient explanation and fully understood this study, and voluntarily decided to participate and agreed in writing to comply with the precautions
•A subject determined eligible for this study by investigator based physical examination, clinical laboratory tests, interview, etc.

排除标准

•A subject with clinically significant hepatobiliary (severe hepatic impairment, etc.), renal (severe renal impairment, etc.), neurologic, immunologic, respiratory, gastrointestinal, endocrine, blood•oncology, cardiovascular (heart failure, Torsades de pointes, etc.), urinary, or, psychical diseases (except for simple dental past history such as tartar, impacted tooth, or wisdom tooth) or a history
•A subject who has hypersensitivity to the investigational products, drugs containing the same class, or other drugs (penicillin and antibiotics, etc.), or a history of clinically significant hypersensitivity
•A subject with a history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (except for simple appendectomy and herniotomy) that may affect the safety and pharmacokinetics of the investigational products
•A subject with the following results in the screening test:
•Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
•QTc interval: > 450 ms
•Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
•A subject with systolic blood pressure < 80 mmHg or > 160 mmHg, or diastolic blood pressure < 50 mmHg or > 100 mmHg when vital signs are measured in sitting position after resting for at least 3 minutes
•A subject with a history of drug abuse
•A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug, health functional food or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator), or is expected to administer it
•A subject who administered drugs that induce (such as barbitals) or inhibit (such as clarithromycin) the drug metabolizing enzymes within 1 month prior to the expected date of the first dose
•A subject who participated in other clinical trial or bioequivalence study within 6 months prior to the expected date of the first dose
•A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
•A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
•A subject with inability to refrain from grapefruit-containing food from 3 days before the expected date of the first dose until the last discharge
•A subject with excessive caffeine intake (> 5 units/day), or inability to refrain from caffeine or caffeine-containing food from 3 days before the expected date of the first dose until the last discharge
•A subject with inability to use a medically acceptable double contraception or contraception throughout the study and for at least 4 weeks after the last dose, and with inability to agree to donate sperm until the period

研究组 & 干预措施

Itraconazole 200 mg under fasted condition

Experimental

A single oral administration of itraconazole 200 mg under fasted condition

干预措施: Itraconazole 200 mg (Drug)

Itraconazole 200 mg under fed condition

Experimental

A single oral administration of itraconazole 200 mg under fed condition

干预措施: Itraconazole 200 mg (Drug)

Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition

Experimental

Oral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition

干预措施: Itraconazole 200 mg (Drug)

Esomeprazole 40 mg + Itraconazole 200 mg under fasted condition

Experimental

Oral administration of esomeprazole 40 mg once daily for 6 days and then a single oral administration of itraconazole 200 mg under fasted condition

干预措施: Esomeprazole 40 mg (Drug)