Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

Inclusion criteria

• ethnic origin: Caucasian
• body mass index: ≥ 18.5 kg/m² and ≤ 30 kg/m²
• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
• written informed consent

Exclusion criteria

• weight less than 45 kg
• claustrophobia
• tinnitus
• cardiac pacemakers, metallic, plastic or silicone implants, dental retainer or metal-containing tattoos and piercings, Permanent Make-Ups, intrauterine devices
• known allergic reactions/ hypersensitivity to the active ingredients used or to constituents of the study medication (e.g. lactose, lecithin, sulfonamides, salicylates)
• bronchial asthma (all stages) and other known allergic diseases
• existing cardiac, haematopoietic or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics or the requirements for the magnetic resonance tomography
• known hyperkalemia, hyponatremia or hypovolemia or medications that may cause these conditions.
• Hepatic, renal or metabolic diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication (e.g. liver failure, kidney failure, acute intermittent porphyria).
• gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes and interfering with pharmacokinetics and pharmacodynamics of the study medication (e.g. ileus)
• Erythema exsudativum multiforme.
• Glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
• Acute, chronic or recurrent infections.
• drug or alcohol dependence
• positive drug or alcohol screening
• smokers of 10 or more cigarettes per day
• positive results in HIV, hepatitis B virus and hepatitis C virus screenings
• subjects who are on a diet which could affect gastrointestinal motility or the pharmacokinetics of the drug (vegetarian, vegan)
• eating disorders e.g. anorexia, bulimia
• heavy tea or coffee drinkers (more than 1l per day)
• lactation and/or pregnancy test positive or not performed
• subjects suspected or known not to follow instructions
• subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
• subjects liable to orthostatic dysregulation, fainting or blackouts
• participation in a clinical trial during the last 3 months prior to the planned start of the study less than 3 months after last blood donation
• therapy with transdermal patches
• any systemically available medication within 2 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives)
• intake of grapefruit or poppy seeds containing products within 14 days prior to the start of the study
• Females who don't fulfil the criteria for contraception as listed in section 7.5.1 of this protocol