Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?
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
- Change in Area Under Curve (AUC) 0-24h of metformin
研究概览
简要总结
The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 18-64 years
- •Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
- •Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose
排除标准
- •Chronic alcohol abuse
- •Hypersensitivity to metformin or St John's Wort
- •Daily intake of drugs requiring prescription
研究组 & 干预措施
Metformin
7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated.
Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again
干预措施: St John's Wort (Other)
Metformin
7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated.
Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Area Under Curve (AUC) 0-24h of metformin
时间窗: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion
Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort
次要结局
- Pharmacokinetics of metformin(Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below)
- Change in messenger RiboNucleic Acid (mRNA)(Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day))
- Oral glucose tolerance test (OGTT)(During the first 2 hours of each metformin ingestion)
研究者
Tore B. Stage
M.Sc. Pharm
University of Southern Denmark