NCT04712838已完成1 期
Study on the Bioavailability of SHR0302 Tablets With 3 Different Formulations in Healthy Subjects (Single Center, Random, Open, 3 Cycles, 6 Sequences)
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
- 试验地点
- 1
- 主要终点
- The peak plasma concentration (Cmax) of SHR0302.
研究概览
简要总结
The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.
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
- •Volunteer to sign an informed consent form before the start of the relevant activities of this trial, understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial
- •18~45 years old (including both ends, subject to when signing the informed consent form), healthy male
- •Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both ends)
- •Those who have signed the informed consent and have no birth plan within 6 months after the last administration, and agree to take effective contraceptive measures
- •Able to communicate well with the researcher, and understand and comply with the requirements of this research
排除标准
- •Suspected of being allergic to the study drug or any ingredient in the study drug, or allergic
- •Those who have participated in clinical trials of any drugs and medical devices within six months before screening (subject to the signed informed consent form)
- •Subjects with any systemic inflammatory disease or autoimmune disease
- •Subjects with a history of recurrent herpes zoster, disseminated herpes zoster or disseminated herpes simplex
- •Subjects with a history of malignant tumors
- •Subjects with mental or neurological diseases, unwilling to communicate or have language barriers, unable to fully understand and cooperate
- •Those who have a history of tuberculosis (TB) within six months before screening, or have clinical or imaging evidence of active or occult TB
- •Routine blood examination during the screening period: white blood cell count <3.0×109/L and/or neutrophil count <1.5×109/L
- •Subjects Those with serum creatinine> 1.5 mg/dL (133 μmol/L) at the time of screening
- •At the time of screening, 12-ECG check QTcF>450 ms or there are other abnormal conditions judged by the investigator to be clinically meaningful
- •Those who are positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, and HIV antibodies
- •Those who smoked more than 5 cigarettes daily in the 3 months before screening and cannot stop using any Tobacco products
- •Those who drink regularly in the 6 months before screening, drink more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) and cannot stop using any alcoholic products during the trial; those who have a positive alcohol breath test
- •People who have a history of drug abuse, drug dependence or a positive urine drug abuse screening before administration, including: morphine, methamphetamine (methamphetamine), ketamine, cocaine, ecstasy (dimethylene) Dioxyamphetamine), cannabis (tetrahydrocannabinolic acid)
- •Those who have had any surgery within 6 months before screening
- •Infections that require antimicrobial (virus, bacterial, fungal, and parasitic infections) treatment that occurred within 4 weeks before screening
- •Donated blood (or blood loss) within 3 months before screening and donated blood (or blood loss) ≥400 mL, or received blood transfusion
- •Those who have had any acute disease that has been determined by the investigator to be clinically significant within 1 month before screening
- •Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before taking the study drugs; those who plan to take non-study drugs or health products during the trial period
- •The 48 hours before the first dose until the end of the study, the subject refused to stop any methyl yellow Purine beverages or foods, such as coffee, tea, cola, chocolate, etc.; The 7 days before the first dose until the end of the study, the subject refused to stop using any beverages or foods containing grapefruit; there are special dietary requirements that cannot be consistent Eaters
- •Physical examination, vital signs, laboratory examinations, chest X-ray or chest CT, abdominal ultrasound and other abnormal and clinically meaningful examination results
- •The researcher believes that there are other subjects who are not suitable for participating in the research
研究组 & 干预措施
group E
Experimental
干预措施: SHR0302 (Drug)
group C
Experimental
干预措施: SHR0302 (Drug)
group F
Experimental
干预措施: SHR0302 (Drug)
group D
Experimental
干预措施: SHR0302 (Drug)
group B
Experimental
干预措施: SHR0302 (Drug)
group A
Experimental
干预措施: SHR0302 (Drug)
结局指标
主要结局
The peak plasma concentration (Cmax) of SHR0302.
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis.
Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302.
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis.
The relative bioavailability of SHR0302 tablets with 3 different formulations.
时间窗: through study completion, an average of 1 month.
The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time.
次要结局
- The Clearance (CL/F) of SHR0302.(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.)
- Incidence of adverse events.(through study completion, an average of 1 month)
- The Elimination half-life (T1/2) of SHR0302.(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.)
- The apparent volume of distribution (Vz/F) of SHR0302.(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.)
- The Peak Time (Tmax) of SHR0302.(0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.)
研究者
研究点 (1)
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