Clinical Trial on Budesonide 2 single doses, Metronidazole multiple-dose - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Drug: Budesonide 2 single doses, Metronidazole multiple-dose

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:

Effect of budesonide on metronidazole steady-state PK (primarily described as area under the concentration-time-curve).
Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion before and during metronidazole multiple-dose co-administration.
Safety parameters.

Study Type

Interventional

Enrollment (Actual)

12

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
AUC

Secondary Outcome Measures

Outcome Measure
other PK parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Dr. Falk Pharma GmbH

Principal Investigator: Univ. Hosp. Tuebingen, Dept. of Clinical Pharmacology

Investigators

Principal Investigator: Christoph H Gleiter, MD, Department of Clinical Pharmacology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria