A Bioequivalence Study Between the Generic Dasatinib Tablet and Reference Product in Vivo
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum (peak) plasma drug concentration (Cmax)
研究概览
简要总结
This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb after single dose in healthy subjects, so as to provide reference for clinical evaluation and clinical medication; to observe the safety of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions;
- •Subjects were able to complete the study according to the requirements of the trial protocol;
- •Subjects have no disease history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders;
- •Healthy male and female subjects at age of 18-55;
- •Male subjects weighted ≥ 50 kg, female subjects weighted ≥ 45kg, and the body mass index (BMI) was18 kg/m2 to 28 kg/m2 (including the cutoff value).
- •Normal or not clinical significant abnormal vital signs, physical examination, laboratory examination, ECG and imaging examination have;
- •The female blood pregnancy test was negative, and the subjects (including male subjects) had no pregnancy plan from 2 weeks before administration to at least 1 month after the last dose of the study drug and voluntarily took effective contraceptive measures.
排除标准
- •Subjects with the following diseases or with clinically significant abnormalities in clinical laboratory examinations or other clinical findings of clinical significance (including but not limited to gastrointestinal, kidney, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric, cardiovascular and cerebrovascular diseases);
- •Subjects with known allergies to dasatinib or its excipients;
- •Subjects smoked at least 5 cigarettes per day 3 months before screening;
- •Subjects with a history of drug or alcohol abuse;
- •Subjects who donated blood within 3 months before screening;
- •Subjects who took any drugs that could change liver enzyme activity 28 days before taking the study drug;
- •Subjects who have taken any drugs, vitamin products or herbal medicines within 14 days before clinical trial;
- •Subjects who smoked and drank alcohol during the trial, or performed strenuous exercise before the trial;
- •Subjects have taken the study drug and participated in other drug clinical trials within 2 months before the clinical trial;
- •Subjects with abnormal vital sign results;
- •Subjects with abnormal clinical medical investigation;
- •Subjects who had clinically significant ECG abnormalities;
- •Subjects with abnormal chest X-rays;
- •Subjects with the positive results of Hepatitis (including hepatitis B and C), AIDS, and syphilis;
- •Female subjects who were lactating or serum-positive for pregnancy;
- •Those who screen positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial;
- •Subjects with acute illnesses that occurred during the screening period or prior to study drug administration;
- •Acute disease occurs during pre-study screening stage or before study medication
- •Subjects with a history of peptic ulcer or intracranial hemorrhage;
- •Subjects had any disease that increased the risk of bleeding,
- •Subjects were unable to comply with ward management regulations;
- •Subjects cannot complete the trial for personal reasons;
- •Subjects judged unsuitable for participating in this trial by other investigators.
研究组 & 干预措施
CTTTQ Dasatinib tablet
Subjects receive CTTQ dasatinib tablet under fasting/fed
干预措施: CTTQ Dasatinib tablet (Drug)
Sprycel Sprycel
Subjects receive Sprycel under fasting/fed
干预措施: Sprycel Dasatinib tablet (Drug)
结局指标
主要结局
Maximum (peak) plasma drug concentration (Cmax)
时间窗: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
时间窗: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
Area under the plasma concentration-time curve from time zero to time t is a Pharmacokinetic parameter
The area under the plasma concentration curve from 0 to infinity (AUC0-∞)
时间窗: 1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.
The area under the plasma concentration curve from 0 to infinity
次要结局
- Time to maximum concentration (Tmax)(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Elimination half-life (t1/2)(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Apparent end elimination rate constant (λz)(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Apparent volume of distribution (Vd/F)(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Apparent total body clearance (CL/F)(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Relative bioavailability(1 hour before administration and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after administration.)
- Adverse Event(Up to day 11)
- Serious Adverse Event(Up to day 11)
- Body temperature(Up to day 11)
- Pulse(Up to day 11)
- Blood pressure(Up to day 11)
- CTCAE v5.0(Up to day 11)
- The Number of participants with abnormal laboratory examinations(Up to day 11)