Pharmacokinetic Interactions of Metamizole (Dipyrone) in Healthy Subjects

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 systemic 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
• •Inability to stop consumption inducing food products (e.g. grapefruit juice) 72 h before start of the study
• •Excessive caffeine consumption (\>8 cups of coffee/ 8l coca cola per day)
• •Legal incapacity or limited legal capacity at screening
• •Positive results from urine drug screen at screening
• •History or clinical evidence of any disease (e.g. gastrointestinal disease: Morbus Crohn, Colitis Ulcerosa, anamnestic gastrointestinal bleeding) and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
• •Known hypersensitivity to Metamizole (Novalgin®) or excipients of the drug formulation
• •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.