NCT06147908已完成1 期
A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers
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
- 54
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male Volunteers who are ≥19 years old
- •Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
排除标准
- •Clinically significant Medical History
研究组 & 干预措施
Sequence A
Experimental
cross-over
干预措施: DW5221 (Drug)
Sequence A
Experimental
cross-over
干预措施: DW5221-R (Drug)
Sequence B
Experimental
cross-over
干预措施: DW5221 (Drug)
Sequence B
Experimental
cross-over
干预措施: DW5221-R (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: up to 120 hour
Pharmacokinetics of Megestrol Acetate
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 120 hour
Pharmacokinetics of Megestrol Acetate
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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