Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.
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|ClinicalTrials.gov Identifier: NCT00777855|
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : July 17, 2013
Last Update Posted : July 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: warfarin plus rifampin Drug: warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Rifampin on the Pharmacokinetics of Warfarin in Healthy Volunteers.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
|Experimental: warfarin then warfarin plus rifampin||
Drug: warfarin plus rifampin
warfarin 7.5mg po x 1; rifampin 600mg IV x 1
warfarin 7.5mg po x 1
- S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours. [ Time Frame: 0-12 hours after warfarin dosing ]Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin [ Time Frame: 0-120 hours after warfarin dosing ]Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
- Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin [ Time Frame: 0-120 hours after warfarin dosing ]Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.
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): NCT00777855
|United States, California|
|UCSF Medical Center|
|San Francisco, California, United States, 94112|
|Principal Investigator:||Leslie Z Benet, PhD||University of California, San Francisco|