Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
NCT00338910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2007-12-11
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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