Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)of clomiphene
研究概览
简要总结
Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female caucasians
- •Age 18 - 45 years old
- •BMI 18.5 - 26 kg/m2
排除标准
- •Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
- •Pregnancy/lactation period
- •Meno-/postmenopausal
研究组 & 干预措施
CYP2D6 EM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: Clomiphene (Drug)
CYP2D6 EM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and paroxetine (Drug)
CYP2D6 EM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and clarithromycin (Drug)
CYP2D6 IM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: Clomiphene (Drug)
CYP2D6 IM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and paroxetine (Drug)
CYP2D6 IM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and clarithromycin (Drug)
CYP2D6 PM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: Clomiphene (Drug)
CYP2D6 PM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and paroxetine (Drug)
CYP2D6 PM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and clarithromycin (Drug)
CYP2D6 UM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: Clomiphene (Drug)
CYP2D6 UM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and paroxetine (Drug)
CYP2D6 UM
clomiphene, clomiphene and paroxetine, clomiphene and clarithromycin
干预措施: clomiphene and clarithromycin (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)of clomiphene
时间窗: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application
AUC of clomiphene and metabolites
Peak Plasma Concentration (Cmax)of Clomiphene
时间窗: 1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application
Cmax of Clomiphene and metabolites
次要结局
- Clearance of Clomiphene(4, 8, 12 and 24 hours after drug application)
- Metabolomic(4, 8, 12 and 24 hours after drug application)
- Tmax of clomiphene(4, 8, 12, 24 hours after drug application)
- Pharmacogenomics(once)
研究者
Matthias Schwab
Prof. M.D.
Robert Bosch Gesellschaft für Medizinische Forschung mbH