Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborators: Dr. Falk Pharma GmbH; Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
• Treatments: Budesonide; Metronidazole

Criteria

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)