ACTRN12619001444178已完成1 期
A randomised, open-label, two-way crossover study comparing the pharmacokineticsof a solid dosage form and a solution of PN-943 in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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
- •Normal healthy volunteers 18-55 years
- •Good general health,
- •BMI 18-30kg/m2
- •Non-smokers
- •Lab values within normal range. Willing to consume standard meal provided (Standard meal will be as advised by the clinic and principal investigator).
- •Ability and willingness to attend visits to the site and provide written informed consent prior to entry into the study.
排除标准
- •History of significant abnormalities or diseases
- •Clinical significant lab or ECG abnormalities
- •History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular,
- •haematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- •History of neoplastic disease
- •Mentally or legally incapacitated
- •History of severe allergic or anaphylactic reactions
- •History of substance abuse, severe allergic or anaphylactic reactions. Regular Alcohol consumption (>21units per week).
- •Clinically significant lab abnormality or ECG
- •Inability to comply with the requirements of the study protocol
研究者
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