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Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

Information source: University Hospital Tuebingen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Budesonide 2 single doses, Metronidazole multiple-dose (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital Tuebingen

Official(s) and/or principal investigator(s):
Christoph H Gleiter, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology

Summary

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

Clinical Details

Official title: Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AUC

Secondary outcome: other PK parameters

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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)

Locations and Contacts

Additional Information

Starting date: May 2006
Last updated: December 10, 2007

Page last updated: August 23, 2015

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