NCT00338910

Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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-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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-05-01
• Completion: 2006-06-01
• First posted: 2006-06-20
• Last updated: 2007-12-11