Pentriox - Induction of Oxidative Stress
Phase 1
Completed
- Conditions
- Oxidative Stress
- Interventions
- Registration Number
- NCT02188472
- Lead Sponsor
- Henrik Enghusen Poulsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
Inclusion Criteria
- Caucasian
- healthy men
- non-smoker
- 18-35 years
- BMI: 18-30
Exclusion Criteria
- Smoker
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 2 Placebo Tablets twice daily for 7 days Penicillin V Penicillin V Penicillin V 2 tablets of 330 mg twice dayly for 7 days Trimethoprim Trimethoprim 2 Tablet Trimethoprim of 100 mg twice daily for 7 days
- Primary Outcome Measures
Name Time Method Urinary excretion of 8-oxoguanosine (nmol/24h) Change from Baseline after seven days of treatment Urinary excretion of 8-oxodeoxoguanosine (nmol/24h) Change from Baseline after seven days of treatment
- Secondary Outcome Measures
Name Time Method Malondialdehyde At the screening visit and at the final visit
Trial Locations
- Locations (1)
Department of Clinical Pharmacology
🇩🇰Copenhagen, Denmark