Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under the Plasma concentration versus time curve (AUC0-t)
研究概览
简要总结
This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.
详细描述
Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions.
The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA).
A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •Caucasian male or female subjects aged between ≥18 and ≤55years
- •Physically and mentally healthy
- •BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
- •Non-smoker
- •If female, the pregnancy test at screening and at admission must be negative
排除标准
- •Known or suspected hypersensitivity to study drugs
- •history of, any clinically significant diseases
- •Positive test of hepatitis B, hepatitis C or HIV Screening
- •Known photohypersensitivity
研究组 & 干预措施
Probe drug cocktail / Ze 117
One-sequence, Probe drug cocktail alone and in combination with Ze 117.
干预措施: Ze 117 (Drug)
Probe drug cocktail / Ze 117
One-sequence, Probe drug cocktail alone and in combination with Ze 117.
干预措施: Probe drug cocktail (Drug)
结局指标
主要结局
Area under the Plasma concentration versus time curve (AUC0-t)
时间窗: 72 hours
Pharmacokinetic Parameter AUC0-t (mg\*h/L) of the probe drugs will be determined.
次要结局
- Elimination rate constant (Ke)(72 hours)
- Peak Plasma Concentration (Cmax)(72 hours)
- Elimination half life (t1/2)(72 hours)
- Area under the Plasma concentration versus time curve (AUC0-inf)(72 hours)