Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
研究概览
简要总结
- Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
- Subjects: Healthy subject
- Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.
详细描述
This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 20 and 45 years
- •Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight
- •No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test
排除标准
- •Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen
- •Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases
- •Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study
- •Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg
- •Any surgical or medical conditions that could affect drug absorption
研究组 & 干预措施
Group A
Period 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state
干预措施: Tramadol HCI/Acetaminophen (Drug)
Group B
Period 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state
干预措施: Tramadol HCI/Acetaminophen (Drug)
结局指标
主要结局
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
时间窗: 0 to 36 hour
Bio-equivalence of AUC at steady state of tramadol and acetaminophen
次要结局
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state(0 to 36 hour)