Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

NCT00338910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2007-12-11

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Budesonide 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 & Collaborators

  • Dr. Falk Pharma GmbH

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

    collaborator UNKNOWN
  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christoph H Gleiter, MD · Department of Clinical Pharmacology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338910 on ClinicalTrials.gov