NCT01253122已完成1 期
Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Relative bioavailability
研究概览
简要总结
A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female 55 and over
- •No clinically important abnormal physical finding
- •No clinically significant lab results
- •Normal ECG, Normal BP and HR,BMI between 19 and 32
- •Weight 50 to 100 kg, Able to communicate
- •Provide written informed consent
- •Non smokers
- •Males to use contraception
- •Females to be surgically sterile or post menopausal
排除标准
- •Administration of any IMP other than study drug within 12 weeks before entry
- •Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
- •Surgical or medical condition that might interfere with IMP
- •History of drug or alcohol abuse
- •Clinically significant allergy requiring treatment
- •Loss of greater than 400ml of blood within 12 weeks.
- •Serious adverse reaction or hypersensitivity to any drug
- •Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening
- •Presence of G6PD at screening
- •History of methaemoglobinaemia
- •Partner who is pregnant of lactating
- •Positive Pregnancy test
研究组 & 干预措施
TRx0037
Experimental
干预措施: TRx0037 (Drug)
TRx0014
Active Comparator
干预措施: TRx0037 (Drug)
结局指标
主要结局
Relative bioavailability
Investigate the relative bioavailability of TRx0037 and TRx0014 at two molar equivalent doses in healthy elderly male and female (post-menopausal/non-childbearing) subjects
次要结局
- Safety, tolerability and pharmacokinetics
研究者
相似试验
终止
2 期
Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01626391TauRx Therapeutics Ltd9
已完成
1 期
Bioavailability of Trazodone Hydrochloride (New Polymer) vs. Trazodone Hydrochloride Contramid® at Steady-state.Bioavailability Heathy VolunteersBioavailability StudyBioequivalanceNCT06773767Aziende Chimiche Riunite Angelini Francesco S.p.A64
已完成
1 期
Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult VolunteersHealthyNCT00839072Labopharm Inc.24
进行中（未招募）
1 期
A Study of Idazoxan in Healthy ParticipantsHealthyNCT05727189Terran Biosciences Australia Pty Ltd150
已完成
1 期
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult MalesHealthyNCT02411500Trevena Inc.18