NCT04400123已完成1 期
A Single-centre, Single-dose, Randomized, Open-label and Two-cycle Crossover Bioequivalence Study of Famitinib Malate Capsules in Old and New Formulation on Healthy Chinese 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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameter: Cmax
研究概览
简要总结
The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects.
The secondary objective is to evaluate the safety after famitinib malate capsules oral dose on healthy Chinese subjects.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18~45 (including 18 and 45 years old);
- •Body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 26kg/m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
- •Consent to abstinence or take effective non-drug contraception measures during the study and for at least 3 months after the last drug administration.
- •The subjects were able to communicate well with the researchers, understand and comply with the requirements of this study, understand and sign the informed consent;
排除标准
- •Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
- •Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
- •Those who donated blood or suffered heavy blood loss (≥200 mL), received blood transfusions, or used blood products within 3 months before enrollment;
- •Have a history of allergies to drugs, food or other substances;
- •Have taken sedatives, sleeping pills or other addictive medicines within 1 year before the study; Those with positive results in urine drug abuse screening;
- •Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
- •Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements);
- •Those who smoked more than 5 cigarettes per day within 3 months before the study and who could not stop using any tobacco products during the study;
- •Regular drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), and any alcohol-containing products cannot be stopped during the study Those who are positive for alcohol breath test;
- •Those with any abnormal result (clinically significant) of vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;
- •Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive;
- •The subject refuses to stop any beverage or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc., within 48 hours before the first dose until the end of the study; The subject refuses to stop any beverage or food containing grapefruit; Those who have special dietary requirements and cannot accept the unified diet;
- •Other factors of the subject that are not suitable for participating in the study judged by the investigators.
研究组 & 干预措施
Treatment group TR
Experimental
Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.
干预措施: Famitinib malate (Drug)
Treatment group RT
Experimental
Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
干预措施: Famitinib malate (Drug)
结局指标
主要结局
Pharmacokinetics parameter: Cmax
时间窗: through study completion, an average of 30 days
Peak plasma concentration （Cmax）
Pharmacokinetics parameter: AUC
时间窗: through study completion, an average of 30 days
Area under the plasma concentration versus time curve（AUC）
次要结局
- Pharmacokinetics parameter: λz(through study completion, an average of 30 days)
- Pharmacokinetics parameter: Tmax(through study completion, an average of 30 days)
- Pharmacokinetics parameter: t1/2(through study completion, an average of 30 days)
- The number of participants with treatment-related adverse events assessed by CTCAE V5.0(through study completion, an average of 30 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Tofacitinib Bioequivalence Study Comparing Tablets And CapsulesHealthyNCT01599377Pfizer50
已完成
1 期
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet FormulationBioequivalenceNCT03708133Bayer24
已完成
1 期
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the BloodHealthyNCT03266705Pfizer30
已完成
1 期
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy SubjectsRelapsing Remitting Multiple SclerosisNCT04570670Banner Life Sciences LLC50
已完成
1 期
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese SubjectsHealthy VolunteersNCT01394224UCB Pharma25