PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Urinary excretion of 8-oxoguanosine (nmol/24h)
研究概览
简要总结
The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and trimethoprim's possible induction of oxidative stress in human cells. The induction is examined by comparing changes in oxidative stress in the treatment group with the change in a placebo group. The study is a randomized-based placebo-controlled study. Each treatment group consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian
- •healthy men
- •non-smoker
- •18-35 years
- •BMI: 18-30
排除标准
- •high blood pressure
- •allergies towards any of the tested medicine
- •galactose-intolerance
- •abnormal lipid profile
- •CRP > 10
- •Glucose/galactose-malabsorption
- •Use of medications and herbal remedies that affect/are affected by v-penicillin and trimethoprim
- •intake of narcotics 2 months prior to trial
- •intake of supplements 1 month prior to trial
- •bronchial asthma
- •allergies
- •heart deficiencies
- •brady cardia
- •kidney disease
- •liver disease
- •hypo-potassium
- •phenylketonuria
研究组 & 干预措施
Penicillin V
Penicillin V 2 tablets of 330 mg twice dayly for 7 days
干预措施: Penicillin V (Drug)
Trimethoprim
2 Tablet Trimethoprim of 100 mg twice daily for 7 days
干预措施: Trimethoprim (Drug)
Placebo
2 Placebo Tablets twice daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary excretion of 8-oxoguanosine (nmol/24h)
时间窗: Change from Baseline after seven days of treatment
Urinary excretion of 8-oxodeoxoguanosine (nmol/24h)
时间窗: Change from Baseline after seven days of treatment
次要结局
- Malondialdehyde(At the screening visit and at the final visit)
研究者
Henrik Enghusen Poulsen
Professor
Rigshospitalet, Denmark