Pentriox - Induction of Oxidative Stress

Study Overview
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Brief Summary
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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.

Official Title
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PENTRIOX - a Randomized, Placebo-controlled Clinical Study on the Possible Induction of Oxidative Stress by Phenoxymethylpenicillin and Trimethoprim on Healthy Volunteers

Conditions
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Oxidative Stress

Intervention / Treatment
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* Drug: Penicillin V
* Drug: Trimethoprim
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Penicillin V<br>Penicillin V 2 tablets of 330 mg twice dayly for 7 days | Drug: Penicillin V<br>* Penicillin V: 2 x 330mg tablets should be taken twice daily<br>* Other names: Penicillin V, Pancillin;|
| Active Comparator: Trimethoprim<br>2 Tablet Trimethoprim of 100 mg twice daily for 7 days | Drug: Trimethoprim<br>* Trimopan: 2 x 100mg tablets should be taken twice daily<br>* Other names: Trimethoprim, Trimopan;|
| Placebo Comparator: Placebo<br>2 Placebo Tablets twice daily for 7 days | Drug: Placebo<br>* Placebo: 2 tablets should be taken twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malondialdehyde |  | At the screening visit and at the final visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative Stress, antibiotics