Clinical trial NCT02426060: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetics parameters like Cmax、tmax and AUC0-t of Warfarin
timeFrame: Predose up to 144 hours post Day 1 and Day 10 dose
Secondary outcomes:
measure: Prothrombintime after Warfarin dosing
timeFrame: 6 hours to 144 hours post Day 1 and Day10 dose
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and technology
state: Hubei
Study officials:
References: