AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
详细描述
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BW is above 50kg and BMI is between 18.5 and 30.0
- •Subject who agreed and signed on informed consent form prior to the study participation
排除标准
- •Presence or history of clinically significant disease
- •Treatment history of any drug which might affect IP within 10days
- •History of other study drugs within 12weeks
研究组 & 干预措施
B group
reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
干预措施: AK-R215 (Drug)
A group
AK-R215, test drug
干预措施: AK-R215 (Drug)
A group
AK-R215, test drug
干预措施: Bazedoxifene 20 mg (Drug)
A group
AK-R215, test drug
干预措施: Cholecalciferol 800IU (Drug)
B group
reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
干预措施: Bazedoxifene 20 mg (Drug)
B group
reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU
干预措施: Cholecalciferol 800IU (Drug)
结局指标
主要结局
AUC0-t
时间窗: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Cmax
时间窗: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
次要结局
- Tmax(0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h)
- T1/2(0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h)
- AUCinf,(0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h)