Inhibition Metamizole 2020

• Status: Completed
• Trial end date: 2020-10-02
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical phase I trial had 3 arms: inhibition by fluconazole, inhibition by ciprofloxacin and placebo. Subjects were treated for 3 days prior to the study day. The intervention was a single dose of 1 gram metamizole. We took blood samples at set time points and analysed the concentration of the main metabolites of metamizole at each time point in plasma.

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

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Dipyrone

Criteria

Inclusion Criteria:

• Body mass index between 18 and 28 kg/m2 (inclusive) and bodyweight at least 50 kg at screening

• Systolic blood pressure: 100-140 mmHg, diastolic blood pressure: 60-90 mmHg and heart rate: 45-90 bpm (inclusive), measured on the leading arm*, in the supine position at screening

• No clinically significant findings on the physical examination on the physical examination at screening

• Signed informed consent prior to any study-mandated procedure

• Haematology and clinical chemistry results not deviating from the normal range to clinically relevant extent at screening

• Ability to communicate well with the investigator to understand and comply with the requirements of the study

Exclusion Criteria:

• Smoking > 5 cigarettes per day

• History or clinical evidence of alcoholism or drug abuse within the 3- year period prior to screening

• Loss of ≥ 250 ml of blood within 3 months prior to screening

• Treatment with an investigational drug within 30 days prior to screening

• Previous treatment with any prescribed or over the counter medication (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of the study

• Legal incapacity or limited legal capacity at screening

• Positive results from urine drug screen at screening

• History or clinical evidence of any disease

• Known hypersensitivity to Metamizole (Novalgin®), ciprofloxacin (Ciproxin®), fluconazole (Diflucan®) or any other excipients in the drug formulation