Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338910
Status:
COMPLETED
Last Update Posted:
2007-12-11
First Post:
2006-06-19
Brief Title:
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None