NCT01368783Unknown1 期
Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic analysis
研究概览
简要总结
Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 20 to 55 years old, with a weight more than 50 kg and with appropriate body mass index (BMI) values within 19-28 kg/m
- •Agreed voluntarily to participate to the study and comply with the study protocol with written permission.
排除标准
- •Has history of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- •Has history of hypersensitivity or clinically significant adverse drug reaction(s) to the study drugs, same class of the study drugs, or other drugs including aspirin and antibiotics.
- •Drinks excessive caffeinated beverages (caffeine >10 units/day), alcohol beverages (alcohol >21 units/week) or smokes excessively (>20 cigarettes/day) or has history of alcoholism.
- •Has been excluded by the researchers due to abnormal findings in screening EKG and/or blood tests
研究组 & 干预措施
atazanavir
Experimental
400 mg/day for 2 days
干预措施: atazanavir (Drug)
Atazanavir and Tenofovir
Experimental
干预措施: Atazanavir(ATZ) and Tenofovir(TDF) (Drug)
Atazanavir and Ritonavir
Experimental
干预措施: Atazanavir(ATZ) + Ritonavir (Drug)
Atazanavir + tenofovir + ritonavir
Experimental
干预措施: atazanavir(ATZ) + tenofovir(TDF) + ritonavir (Drug)
结局指标
主要结局
Pharmacokinetic analysis
maximum concentration at steady status(Cmax,ss)
次要结局
- Pharmacokinetic evaluation
研究者
研究点 (1)
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