Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00338910|
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 11, 2007
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Budesonide 2 single doses, Metronidazole multiple-dose||Phase 4|
The primary objective of this study is to describe a possible effect of metronidazole on PK of budesonide in healthy volunteers.
- 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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||June 2006|
- 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.
- other PK parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338910
|Principal Investigator:||Christoph H Gleiter, MD||Department of Clinical Pharmacology|