Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)0-∞
研究概览
简要总结
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.
详细描述
Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 18 and above.
- •The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
- •The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
- •The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
排除标准
- •Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
研究组 & 干预措施
Rivaroxaban 20 MG Oral Tablet [Xarelto]
rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg
干预措施: Rivaroxaban 20 MG Oral Tablet (Drug)
Rivaroxaban 20 MG Oral Tablet
rivaroxaban oral tablet at a single oral dose of 20 mg
干预措施: Rivaroxaban 20 MG Oral Tablet [Xarelto] (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 94 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)
时间窗: 94 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 94 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
次要结局
- Incidence of abnormal pulse(94 days)
- Incidence of abnormal temperature(94 days)
- Incidence of abnormal electrocardiogram waveform(94 days)
- Incidence of Treatment-Emergent Adverse Events(94 days)
- Incidence of abnormal blood pressure(94 days)