Healthy male volunteers
Conditions
Interventions
Trade Name: Budenofalk 3 mg
Product Name: Budenofalk 3 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: budesonide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) Healthy male subjects b) Caucasian origin c) age: between 18 and 55 years (inclusive) d) body mass index (BMI) within 18-30 kg/m² e) body weight at least 50 kg, at most 100 kg f) non-smoker (or ex-smoker =1 year), proven by urine cotinine =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) subjects with contraindications for budesonide such as hypersensitivity to budesonide or any of the other ingredients, local infections of the intestine (bacteria, fungi, amoebae, viruses), liver cirrhosis and signs of portal hypertension (e.g., in the late stage of primary biliary cirrhosis) or subjects with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma or cataract b) subjects with contraindications for metronidazole: hypersensitivity to metronidazole or other 5-nitroimidazole agents, severe hepatic disease, blood dyscrasia (prior or current history), and central or peripheral nervous system diseases c) history or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics d) history or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food e) clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables f) current smoker or ex-smoker =1 year g) excessive alcohol consumption (³35 g/day in males and ³25 g/day in females) h) abuse of drugs i) positive drug screening j) positive anti-HIV-test, HBsAg-test or anti-HCV-test k) proneness to orthostatic dysregulation, faintings, or blackouts l) heavy tea or coffee drinkers (more than 1 l ˜ 6 cups per day) m) administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial n) repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation (CYP3A inducers/inhibitors), e.g., barbiturates, cimetidine, phenytoin, rifampicin, amiodarone, clarithromycin, erythromycin, fluoxetine, fluvoxamine, ciprofloxacin, norfloxacin, fluconazole, itraconazole, ketoconazole, nefazodone, ethinylestradiol, ciclosporin, carbamazepine, corticosteroids, rifabutin, St. John’s Wort, diltiazem, verapamil, pioglitazone, modafinil o) any medication including OTC medication within the last 14 days prior to study day 1 or during the trial (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives) p) intake of grapefruit-containing food or beverages within 7 days prior to study day or during the trial q) clinically relevant acute or chronic bacterial, fungal or viral infections r) surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy) s) vegetarian diet or other peculiar dietary habits which would preclude the subject’s acceptance of standardized (non-vegetarian) meals t) subjects suspected or known not to follow instructions u) 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 v) patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions w) vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator) x) bloo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers. A clinically relevant interaction will be determined by comparing PK of budesonide and its CYP3A-dependent metabolites 6ß-hydroxybudesonide and 16a-hydroxyprednisolone (quantified primarily by the area under the concentration-time-curves) before and during metronidazole multiple-dose co-administration.;Secondary Objective: Secondary objectives: a) Effect of budesonide on metronidazole steady-state PK (primarily described as AUC). b) Urinary 6ß-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration. c) Safety parameters.;Primary end point(s): The main objectives of the trial have to be determinable in 12 volunteers who have completed the study. | — |
Countries
Germany
Outcome results
None listed