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A Drug Drug Interaciton Study of Imrecoxib and Warfarin in Healthy Volunteers

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Imrecoxib
Warfarin
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Adult males aged 18 to 40 years,with BMI 19~24.

Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG.

Willing and able to provide written informed consent.

Exclusion Criteria:

History of hypersensitivity to Imrecoxib and its components.

History or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, neurological, or psychiatric diseases, or any conditions that may place the subject at increased risk as determined by the investigator.

Any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

History of alcohol dependent, habitual heavy users of caffeinated beverages judged by the investigator.

Have had significant blood loss (>200mL) or have donated 1 or more units of blood or plasma within 12 weeks prior to study entry.

Have a positive test at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb).

Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome (CYP) P450enzymesincluding CYP3A4, CYP2C8 and CYP2C9 within 4 weeks prior to the first dose and throughout the study.

Sites / Locations

  • Union Hospital Tongji Medical College Huazhong University of Science and technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imrecoxib&Warfarin

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics parameters like Cmax、tmax and AUC0-t of Warfarin

Secondary Outcome Measures

Prothrombintime after Warfarin dosing

Full Information

First Posted
April 21, 2015
Last Updated
April 23, 2015
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02426060
Brief Title
A Drug Drug Interaciton Study of Imrecoxib and Warfarin in Healthy Volunteers
Official Title
Effect of Imrecoxib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imrecoxib&Warfarin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imrecoxib
Intervention Type
Drug
Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Prothrombintime after Warfarin dosing
Time Frame
6 hours to 144 hours post Day 1 and Day10 dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult males aged 18 to 40 years,with BMI 19~24. Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG. Willing and able to provide written informed consent. Exclusion Criteria: History of hypersensitivity to Imrecoxib and its components. History or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, neurological, or psychiatric diseases, or any conditions that may place the subject at increased risk as determined by the investigator. Any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. History of alcohol dependent, habitual heavy users of caffeinated beverages judged by the investigator. Have had significant blood loss (>200mL) or have donated 1 or more units of blood or plasma within 12 weeks prior to study entry. Have a positive test at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb). Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome (CYP) P450enzymesincluding CYP3A4, CYP2C8 and CYP2C9 within 4 weeks prior to the first dose and throughout the study.
Facility Information:
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

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A Drug Drug Interaciton Study of Imrecoxib and Warfarin in Healthy Volunteers

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