NCT03456388已完成1 期
A Phase ⅠAscending Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females age 18-45 years
- •Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
- •Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
- •Sign the informed consent form voluntarily and cooperate voluntarily to complete the test
排除标准
- •Allergens (allergic to 2 or more drugs, food or pollen)
- •comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
- •have Clinically significant abnormal screening laboratory values.
- •Systolic pressure > 140mmHg or diastolic > 90 mmHg
- •Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
- •The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
- •Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
- •Have donated blood > 400 ml within 8 weeks prior to screening
- •Participated in other clinical trials within 3 months prior to screening
- •Intaked too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
- •Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
- •Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer half-life
- •Using any psychotropic drug or psychoactive substance
- •Women were screened for positive blood pregnancy
- •The subjects and their partners were not willing to take contraceptives during trial and six months after the study
- •Have a donor plan recently
- •Have participated in this trial
- •The researchers believe that anyone who is unfit to participate in this test will be involved
研究组 & 干预措施
Ammoxetine Hydrochloride Enteric-coated Tablets
Experimental
There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days.
干预措施: Ammoxetine Hydrochloride Enteric-coated Tablets (Drug)
Placebo Enteric-coated Tablets
Active Comparator
There will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets.
干预措施: placebo enteric-coated tablets (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 8 days
Incidence of Adverse Events that researchers determined clinical significance
次要结局
- Pharmacokinetics of blood sample(8 days)
- Mass balance(8 days)
- Pharmacokinetics of urine sample(8days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)Hepatitis BNCT03365947Arrowhead Pharmaceuticals114
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy SubjectsHealthy VolunteersPharmacokinetics of ASP015KNCT02141425Astellas Pharma Global Development, Inc.16
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy ParticipantsHepatitis Delta VirusHepatitis DNCT06740474Assembly Biosciences40
终止
1 期
Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic FibrosisCystic Fibrosis, PulmonaryNCT04375514Arrowhead Pharmaceuticals43
已完成
1 期
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With CholangiocarcinomasCholangiocarcinomaNCT01900158PCI Biotech AS24