A Drug Drug Interaciton Study of Imrecoxib and Warfarin in Healthy Volunteers
This trial is active, not recruiting.
|Sponsor||Jiangsu HengRui Medicine Co., Ltd.|
|Start date||January 2015|
|End date||March 2015|
|Trial size||12 participants|
|Trial identifier||NCT02426060, ARXBDDI-1|
The objective of this study was to determine the effects of Imrecoxib, an anti-infiammatory/analgesic agent that primarily inhibits COX-2 and not COX-1 at therapeutic doses, on the steady-state pharmacokinetic profile and hypoprothrombinemic effect of warfarin in healthy volunteers.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||single group assignment|
Pharmacokinetics parameters like Cmax、tmax and AUC0-t of Warfarin
time frame: Predose up to 144 hours post Day 1 and Day 10 dose
Prothrombintime after Warfarin dosing
time frame: 6 hours to 144 hours post Day 1 and Day10 dose
Male participants from 18 years up to 40 years old.
|Official title||Effect of Imrecoxib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects|
|Description||This is a single center open label study to assess the effect of Imrecoxib on the PK of Warfarin in Healthy Volunteers. The goals of this study are as follows: assess the PK of warfarin when administered alone ,and with Imrecoxib ; assess INR of warfarin when administered alone, and with Imrecoxib; to assess the effect of Imrecoxib on the PK/PD of warfarin, to assess the safety and tolerability of warfarin administered with Imrecoxib.|
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