ACTRN12621001019897已完成1 期
An Exploratory Pharmacokinetic Study to Evaluate the Exposure of R3R01 afterAdministration as New Polymorph in Healthy Subjects
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •18 to 45 years of age
- •-A BMI between 18 to 32 kg/m2
- •-Participants of childbearing potential must agree use highly effective methods of contraception
排除标准
- •-Participation in an investigational drug/device study within 3 months
- •- A history of clinically significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, broncho-pulmonary or neurological conditions, allergic disease or lipid metabolism disorders.
- •- A history of clinically significant drug hypersensitivity.
- •-A known history of porphyria, myopathy, or an active liver disease.
- •-Total bilirubin exceeding 1.5-fold upper limit of normal.
- •-clinically significant symptoms of an infectious illness within four weeks of dosing or a history of recurrent infections.
- •-Positive urine, breath or blood test for drugs of abuse and alcohol
- •- Positive for hepatitis B, hepatitis C, or HIV 1 and 2
- •- Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg and heart rate greater than 100 or less than 45 beats per minute.
- •-Personal or family history of congenital long QT syndrome.
- •- ECGs with QRS and/or T-wave judged by the investigator to be unfavorable
- •-Clinically significant abnormalities in laboratory test results
- •-Donation of blood over 450 mL within three months prior to screening.
- •- Smoker or non-smoker less than 6 months.
- •- Taking any drug or herbal medication that is an inhibitor or inducer of CYP450 within 4 weeks prior to the first dosing.
- •- Use of any prescription drug within 7 days of first dose of study drug
- •- Administration of live (attenuated) vaccines within 4 weeks before dosing
研究者
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