NCT01429675已完成1 期
Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Ibandronate Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Complex Tablet) and a 150mg Ibandronate Tablet in Healthy Adult Volunteers
Alvogen Korea1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Composite of pharmacokinetics
研究概览
简要总结
The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd) after oral administration in healthy adult volunteers.
详细描述
The number of patient is eighty-four. Patients were randomly assigned either a Bonviva tablet(150mg Ibandronate, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Bonviva tablet(150mg Ibandronate, qd) second.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to 55 years of healthy volunteers
排除标准
- •Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
研究组 & 干预措施
Bonviva
Active Comparator
干预措施: bonviva (Drug)
DP-R206
Experimental
干预措施: bonviva (Drug)
结局指标
主要结局
Composite of pharmacokinetics
时间窗: predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose
Cmax, AUClast
次要结局
- Composite of pharmacokinetics(predose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 32, 48, 72, 120 hours post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult VolunteersHealthyNCT01577849Alvogen Korea36
已完成
1 期
DP-R213 Phase 1 Pharmacokinetics StudyHealthyNCT03010267Alvogen Korea46
已完成
1 期
DP-R213 Pharmacokinetics StudyHealthyNCT02762643Alvogen Korea61
已完成
1 期
Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male VolunteersHealthyNCT01421563Alvogen Korea36
已完成
1 期
PK, Dose Proportionality, Food Effect And Repeat Dose Study Of Rosiglitazone XR In Healthy VolunteersAlzheimer's DiseaseNCT00733785GlaxoSmithKline60