This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments imrecoxib, warfarin
Phase phase 1
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Pharmacokinetics parameters like Cmax、tmax and AUC0-t of Warfarin
time frame: Predose up to 144 hours post Day 1 and Day 10 dose

Secondary Outcomes

Prothrombintime after Warfarin dosing
time frame: 6 hours to 144 hours post Day 1 and Day10 dose

Eligibility Criteria

Male participants from 18 years up to 40 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      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.
      Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
      Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..