Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria
研究概览
简要总结
The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, ages ≥18 years
- •Subjects who are qualified professional sensory panelists
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment
排除标准
- •Any acute or chronic condition that may alter taste or smell sensory perception
- •Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration
- •Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody
研究组 & 干预措施
Atazanavir and Cobicistat
Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API)
Stage 2:Taste Optimization using API (flavours and sweeteners)
Stage 3:Prototypes of the API - containing clinical trial materials
干预措施: Atazanavir (Drug)
Atazanavir and Cobicistat
Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API)
Stage 2:Taste Optimization using API (flavours and sweeteners)
Stage 3:Prototypes of the API - containing clinical trial materials
干预措施: Cobicistat (Drug)
Atazanavir and Cobicistat
Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API)
Stage 2:Taste Optimization using API (flavours and sweeteners)
Stage 3:Prototypes of the API - containing clinical trial materials
干预措施: Active Pharmaceutical Ingredient (Drug)
结局指标
主要结局
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria
时间窗: Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria
时间窗: Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria
时间窗: Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria
时间窗: Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria
时间窗: Every 6 weeks from the time of subject enrollment up to 2 years
次要结局
未报告次要终点