Pentriox - Induction of Oxidative Stress (PENTRIOX)

Henrik Enghusen Poulsen

Status and phase: Completed; Phase 1

Conditions: Oxidative Stress

Treatments: Drug: Trimethoprim; Drug: Placebo; Drug: Penicillin V

Study type: Interventional

Funder types: Other

Identifiers

NCT02188472

PEN1011

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Penicillin V

Active Comparator group

Description:

Penicillin V 2 tablets of 330 mg twice dayly for 7 days

Treatment:

Drug: Penicillin V

Trimethoprim

Active Comparator group

Description:

2 Tablet Trimethoprim of 100 mg twice daily for 7 days

Treatment:

Drug: Trimethoprim

Placebo

Placebo Comparator group

Description:

2 Placebo Tablets twice daily for 7 days

Treatment:

Drug: Placebo