Status:
COMPLETED
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00338910
Start Date
May 1 2006
End Date
June 1 2006
Last Update
December 11 2007
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