ACTRN12620000192987已完成1 期
A Randomized, Single-Dose and Multiple Dose Dose-Ranging Safety and Pharmacokinetics Study of Tacrolimus Powder for Inhalation in Healthy Adult Subjects
TFF Pharmaceuticals Australia Pty Limited0 个研究点目标入组 64 人开始时间: 2020年2月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy, adult, male or female (women of non-child bearing potential only),
- •2. Continuous non smoker who has not used nicotine containing products (including e vaping) for at least 3 months prior to the first dosing and throughout the study, based on subject’s self-reporting and urine cotinine levels at screening.
- •3. Medically healthy with no clinically significant medical history, physical and neurologic examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- •4. A CKD-EPI Creatinine 2009 estimated creatinine clearance of >=80 mL/min
- •5. A non vasectomized, male subject must agree to use a highly effective method of birth control with female partners of childbearing potential during the study and for 120 days following dosing.
排除标准
- •1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •2. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •3. History or presence of hypersensitivity or idiosyncratic reaction to tacrolimus, cyclosporine, or any chemically related compound (everolimus, sirolimus).
- •4. History of lactase deficiency
- •5. Has had surgery or any medical condition within 6 months prior to first dosing which may affect the absorption, distribution, metabolism, or elimination of the study drug, in the opinion of the PI or designee.
- •6. Female subjects with a positive pregnancy test or who are lactating.
- •7. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •8 ECG findings are abnormal.
- •9. Blood pressure is abnormal.
- •10. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
研究者
相似试验
已完成
1 期
Comparative assessment of the absorption of a generic formulation of N-acetyl-5-methoxytryptamine prolonged release tablet against the innovator N-acetyl-5-methoxytryptamine prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.N-acetyl-5-methoxytryptamine is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.Mental Health - Other mental health disordersNeurological - Other neurological disordersACTRN12622000957796Zenith Technology Corporation Limited34
已完成
1 期
Comparative assessment of the absorption of a generic formulation of N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet against the innovator N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide prolonged release tablet conducted under fasting conditions and at steady state in healthy male and female volunteers.-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.Mental Health - Other mental health disordersNeurological - Other neurological disordersACTRN12622000109707Zenith Technology Corporation Limited28
已完成
1 期
A Randomized, Single-Dose, Two-way Crossover, Open-label Study to Evaluate the Pharmacokinetics of Etoricoxib Tablet 120 mg and Arcoxia(R) 120 mg in Healthy Thai Subjects under Fasting ConditionsHealthy volunteersBioequivalenceEtoricoxibPharmacokinetic studyTCTR20190428001Abbott Healthcare Products B.V.36
已完成
1 期
A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3002813 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease or Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseJPRN-jRCT2080222069Eli Lilly Japan K.K.
已完成
1 期
Dose escalation, placebo-controlled phase 1 study to assess the safety and tolerability of CSL324 in healthy adultsACTRN12616000846426CSL Limited56