An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
排除标准
- •Significant acute or chronic medical illness
- •History of a clinically significant drug rash, Stevens-Johnson Syndrome or Gilbert's Syndrome
- •Inability to swallow oral medication
- •Major surgery within 4 weeks of study treatment administration
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment Sequence Group 3
干预措施: Atazanavir/Cobicistat Mini-tablet (Drug)
Treatment Sequence Group 3
干预措施: Atazanavir (Drug)
Treatment Sequence Group 3
干预措施: Cobicistat (Drug)
Treatment Sequence Group 1
干预措施: Atazanavir (Drug)
Treatment Sequence Group 1
干预措施: Cobicistat (Drug)
Treatment Sequence Group 1
干预措施: Atazanavir/Cobicistat Mini-tablet (Drug)
Treatment Sequence Group 2
干预措施: Atazanavir (Drug)
Treatment Sequence Group 2
干预措施: Cobicistat (Drug)
Treatment Sequence Group 2
干预措施: Atazanavir/Cobicistat Mini-tablet (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to 17 days
次要结局
- Apparent terminal plasma half-life (T-HALF)(Up to 17 days)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])(Up to 17 days)
- Observed plasma concentration at 24 hours (C24)(Up to 17 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 17 days)
- Number of participants with Adverse Events (AEs)(Up to 75 days)
- Number of participants with vital sign abnormalities(Up to 17 days)
- Changes in Taste Evaluation Questionnaire(Up to 17 days)
- Number of participants with clinical laboratory abnormalities(Up to 17 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 17 days)
- Number of participants with Serious Adverse Events (SAEs)(Up to 75 days)
- Number of participants with AEs leading to discontinuation(Up to 75 days)
- Number of participants with AEs leading to death(Up to 75 days)
