An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
研究概览
简要总结
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.
详细描述
A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.
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
- •Overall healthy subjects, non-childbearing females included.
排除标准
- •Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- •Pregnant or breast-feeding female.
- •Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
- •Positive screen for drugs of abuse, alcohol, or cotinine.
- •Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
- •Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
研究组 & 干预措施
Tablet 1 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid.
干预措施: ABT-072 (Drug)
Tablet 2 vs. Capsule
Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid.
干预措施: ABT-072 (Drug)
结局指标
主要结局
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
时间窗: 4 days post each dose
次要结局
- To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.(Through 14 days post last dose.)