ACTRN12620000573954已完成1 期
The Relative Oral Bioavailability of a Tablet Formulation vs a Solutionof PLN-74809 in Healthy Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years(—)
- 性别
- All
入选标准
- •1. 18 to 55 years
- •2. Good general health, with no significant medical history and no clinically significant
- •abnormalities at screening and/or before administration of the initial dose of study drug.
- •3. Body weight greater than or equal to 50 kg at the Screening Visit.
- •4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- •5. Participants must use adequate contraception for male and female participants of childbearing potential.
- •6. Understand the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •- History of clinically significant abnormalities or diseases.
- •- Pregnant or lactating females.
- •- Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- •- Positive toxicology screening panel
- •- History of substance abuse or dependency or history of recreational drug use.
- •- Alcohol consumption greater than 14 drinks per week for males (7 for females).
- •- Smokers or ‘vapers’ (cigarette or other modalities).
- •- Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
- •- Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
- •- Have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.
研究者
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