Effect of imrecoxib tablets on pharmacokinetics and pharmacodynamics of oral warfarin in healthy subjects

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPB-15005872
• Date of registration: 2015-01-23
• Prospective Registration: Yes
• Primary sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Public title: Effect of imrecoxib tablets on pharmacokinetics and pharmacodynamics of oral warfarin in healthy subjects
• Scientific title: Effect of imrecoxib tablets on pharmacokinetics and pharmacodynamics of oral warfarin in healthy subjects
• Date of first enrolment: 2015-03-01
• Target sample size: Self-controlled group :12;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10317
• Study type: Observational study
• Study design: historical control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Yani Liu
• Affiliation: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Name: Shaojun Shi

Key inclusion & exclusion criteria

Inclusion criteria: All subjects enrolled in this clinical trial must be male healthy nonsmokers, 18 to 40 years of age, with a body mass index (BMI) of 19 to 24 kg/m2. Physical and mental health will be determined by medical interview, complete physical examination, chest X-ray, 12-lead ECG, vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and clinical standard laboratory tests, including hematology (red blood cell count, white blood cell with differential cell count, platelet count, hemoglobin, and hematocrit), blood chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, alkaline phosphatase, albumin, and total protein glucose), and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, nitrites, blood, and leucocytes). Subjects must to test negative for hepatitis C virus, hepatitis B-surface antigen, and HIV. Female volunteers must be required to have a negative pregnancy test at the time of screening.Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria: Volunteers were excluded if they have any clinically significant abnormality, have a history of an allergy or hypersensitivity to any chemicals, have donated blood or participated in another investigational drug study within 12 weeks before entry into this study, or have received any drug treatment within 2 weeks before the study. Volunteers with any history or evidence of a hepatic, renal, gastrointestinal, endocrine, pulmonary, hematological, cardiovascular, vascular, or collagen disease will also be excluded from this study. A history of muscle disease, nervous system disease, or a psychiatric disorder that might hinder compliance with the study protocol, as well as a history of alcohol, tobacco, or drug abuse, are also exclusion criteria.

Age minimum: 20
Age maximum: 30
Gender: Male

Health Condition(s) or Problem(s) studied

Pharmacokinetics and pharmacodynamics

Intervention(s)

Self-controlled group :Phase I:oral administration of 5 mg warfarin; Phase II: oral co-administration of 0.1 g imrecoxib and 5mg warfarin;

Primary Outcome(s)

Plasma R-warfarin and S-warfarin concentration;International normalized ratio;

Source(s) of Monetary Support

Jiang Su Heng Rui Medicine CO,. LTD