A Multiple Dose Bioequivalence Study of Pramipexole With Increasing Doses (0.375mg to 1.5mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375mg Extended Release Tablet q.d. Versus 0.125mg Immediate Release (IR) Tablet t.i.d and 1.5 mg Extended Release Tablet q.d. Versus 0.5mg Immediate Release Tablet t.i.d. in Chinese Healthy Male Volunteers
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
- Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
研究概览
简要总结
To establish bioequivalence at steady state of:
1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status
To investigate dose proportionality of pharmacokinetics parameters for:
1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pramipexole extended release
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
干预措施: pramipexole extended release (Drug)
pramipexole extended release
0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
干预措施: pramipexole immediate release (Drug)
pramipexole immediate release
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
干预措施: pramipexole extended release (Drug)
pramipexole immediate release
0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
干预措施: pramipexole immediate release (Drug)
结局指标
主要结局
Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)
时间窗: 27 days
Cmax = maximum observed concentration of the analyte in plasma at steady state
Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)
时间窗: 27 days
Cmax,ss = maximum observed concentration of the analyte in plasma at steady state
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)
时间窗: 27 days
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)
时间窗: 27 days
AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state
次要结局
- Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)(27 days)
- Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)(27 days)
- Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)(27 days)
- Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)(27 days)
- Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)(27 days)
- Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)(27 days)
- Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)(27 days)
- The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)(27 days)
- Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)(27 days)