Pentriox - Induction of Oxidative Stress

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henrik Enghusen Poulsen
• Collaborators: Klinisk Biokemisk Afdeling; Klinisk farmakologisk Afdeling; Sektion for Biomedicin Institut for Veterinær Patobiologi
• Treatments: Penicillin V; Penicillins; Trimethoprim

Criteria

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