Healthy
Conditions
Keywords
healthy volunteers
Brief summary
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
Detailed description
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers. Secondary objectives: 1. Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve). 2. Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration. 3. Safety parameters.
Interventions
DRUGBudesonide 2 single doses, Metronidazole multiple-dose
Budesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9.
Sponsors
Dr. Falk Pharma GmbH
Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects * Caucasian origin * Age: between 18 and 55 years (inclusive) * Body mass index (BMI) within 18-30 kg/m² * Body weight at least 50 kg, at most 100 kg * Non-smoker (or ex-smoker ≥1 year), proven by urine cotinine \<500 ng/ml * Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm * Normal ECG * Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial * Ability to communicate well with the investigator and comply with the requirements of the entire study * Written consent
Exclusion criteria
* Subjects with contraindications for budesonide * Subjects with contraindications for metronidazole * 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 * History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food * Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables * Current smoker or ex-smoker ≤ 1 year * Excessive alcohol consumption (³ 35 g/day in males) * Abuse of drugs * Positive drug screening * Positive anti-HIV-test, HBsAg-test or anti-HCV-test * Proneness to orthostatic dysregulation, faintings, or blackouts * Heavy tea or coffee drinkers (more than 1 l ≈ 6 cups per day) * Administration of glucocorticosteroids within 6 weeks prior to study day 1 or during the trial * Repeated use of drugs during the last 4 weeks prior to study day 1 or during the trial, which might influence hepatic biotransformation * 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) * Intake of grapefruit-containing food or beverages within 7 days prior to study day 1 or during the trial * Clinically relevant acute or chronic bacterial, fungal or viral infections * Surgery of the gastrointestinal tract which may interfere with drug absorption (not applicable for minor abdominal surgery such as e.g. appendectomy and herniotomy) * Vegetarian diet or other peculiar dietary habits which would preclude the subject's acceptance of standardized (non-vegetarian) meals * 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 * Patients known to be in financial difficulties, which could interfere with their appraisal of the informative instructions * Vulnerable subjects (e.g., persons kept in detention or persons who are depending on the sponsor or the investigator) * Blood donation or other blood loss of more than 400 ml within the last 2 months prior to study day 1 * Participation in a clinical trial within the last 2 months prior to study day 1 (assessed by anamnestic inquiry)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| other PK parameters | — |
Outcome results
None listed