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

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Imrecoxib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02426060
• Other study ID #: ARXBDDI-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 21, 2015
• Last updated: April 23, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Imrecoxib

• Warfarin

Locations

Country	Name	City	State
China	Union Hospital Tongji Medical College Huazhong University of Science and technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters like Cmax?tmax and AUC0-t of Warfarin		Predose up to 144 hours post Day 1 and Day 10 dose	No
Secondary	Prothrombintime after Warfarin dosing		6 hours to 144 hours post Day 1 and Day10 dose	Yes