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Trial record 43 of 733 for:    warfarin

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

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ClinicalTrials.gov Identifier: NCT02426060
Recruitment Status : Unknown
Verified April 2015 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Imrecoxib Drug: Warfarin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Imrecoxib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Imrecoxib&Warfarin Drug: Imrecoxib
Drug: Warfarin



Primary Outcome Measures :
  1. 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 Measures :
  1. Prothrombintime after Warfarin dosing [ Time Frame: 6 hours to 144 hours post Day 1 and Day10 dose ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

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): NCT02426060


Locations
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China, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and technology
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02426060     History of Changes
Other Study ID Numbers: ARXBDDI-1
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Warfarin
Anticoagulants