An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
研究概览
简要总结
The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.
详细描述
This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Low dose ABT-450 capsule and ritonavir capsules (reference).
干预措施: ABT-450 (Drug)
A
Low dose ABT-450 capsule and ritonavir capsules (reference).
干预措施: ritonavir (Drug)
B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
干预措施: ABT-450 (Drug)
B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
干预措施: ritonavir (Drug)
C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
干预措施: ABT-450 (Drug)
C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
干预措施: ritonavir (Drug)
D
High dose ABT-450 capsule and ritonavir capsules (reference).
干预措施: ritonavir (Drug)
D
High dose ABT-450 capsule and ritonavir capsules (reference).
干预措施: ABT-450 (Drug)
E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
干预措施: ritonavir (Drug)
E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
干预措施: ABT-450 (Drug)
结局指标
主要结局
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
时间窗: 72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
时间窗: 72 hrs post dose
次要结局
- To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir(Through 30 days post last dose.)