NCT04197778已完成1 期
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
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
- 14
- 试验地点
- 1
- 主要终点
- Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
研究概览
简要总结
The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, aged 18~
- •Body weight ≥ 50 kg, body mass index (BMI) between 18 to
- •Hemoglobin is in the normal range.
- •Signed informed consent.
排除标准
- •Vital signs, physical examination, laboratory results are abnormal and clinically significant.
- •Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
- •Suspected allergy to the active ingredient or excipient of the experimental drug.
- •Have used erythropoietin within 1 month prior to screening or are currently using erythropoietin.
- •Had donated blood or blood transfusion within 3 months prior to screening.
- •Vein blood collection is difficult or physical condition can not afford blood collection.
- •Hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCVAb), Syphilis antibody, human immunodeficiency virus antibody (HIVAb)were positive.
- •Average daily smoking ≥5 cigarettes within 3 months before screening; average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450mL beer or 150mL wine or 50mL low-alcohol liquor);or 2 days before taking the study drug and during the trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet.
- •3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening.
- •Any health care products, Over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration.
- •With a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive.
- •Subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial.
- •Other conditions in which the study physician considered the subject not suitable for the trial.
研究组 & 干预措施
group A
Experimental
干预措施: DDO-3055 tablet (Drug)
group B
Experimental
干预措施: DDO-3055 tablet (Drug)
结局指标
主要结局
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
时间窗: up to 2 days
Apparent volume of distribution after oral administration (V/F) of DDO-3055
时间窗: up to 2 days
Area under the concentration-time curve (AUC) of DDO-3055
时间窗: up to 2 days
Maximum plasma concentration (Cmax) of DDO-3055
时间窗: up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055
时间窗: up to 2 days
Terminal elimination half-life (T1/2) of DDO-3055
时间窗: up to 2 days
次要结局
- Change of endogenous erythropoietin from baseline(up to 2 days)
- Safety and tolerability(up to 9 days)
研究者
研究点 (1)
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