A Drug Drug Interaciton Study of Imrecoxib and Warfarin in Healthy Volunteers
Effect of Imrecoxib on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 knee-osteoarthritis
Started Jan 2015
Shorter than P25 for phase_1 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedApril 24, 2015
April 1, 2015
2 months
April 21, 2015
April 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics parameters like Cmax、tmax and AUC0-t of Warfarin
Predose up to 144 hours post Day 1 and Day 10 dose
Secondary Outcomes (1)
Prothrombintime after Warfarin dosing
6 hours to 144 hours post Day 1 and Day10 dose
Study Arms (1)
Imrecoxib&Warfarin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital Tongji Medical College Huazhong University of Science and technology
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 24, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
April 24, 2015
Record last verified: 2015-04