Status:
COMPLETED
A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
Lead Sponsor:
Tasly Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the co-administration o...
Detailed Description
Due to a large proportion of patients that could benefit from Dantonic treatment is likely to take warfarin concomitantly. And there is no systematic experience of warfarin drug-drug interaction betwe...
Eligibility Criteria
Inclusion
- Nonsmoking male or female with 18-50 years of age and a body mass index (BMI) from 19.0 to 30.0 kg/m2;
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on medical history, physical examination and laboratory evaluations;
- Taking no medications 2 weeks before Day 0 and during the study, including drugs of abuse, prescription and non prescription medications (including natural health products, Vitamins, and herbals) and did not receive vaccinations;
- Agree to avoid eating Seville oranges, grapefruits (including grapefruit juice), broccoli, brussels sprouts, charcoal-grilled meats, alcoholic beverages, and caffeine- and theobromine-containing beverages and foods from the time of screening visit and the duration of the study;
- Agree to maintain adequate birth control, independent from hormonal contraceptive use, from the time of the screening visit and during the study, at the discretion of the investigator;
- Agree to abstain from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
- A negative fecal occult blood test (FOBT) ;
- Agree to avoid participation in contact sports and/or other activities with significant risk of trauma injury for 7 days after each study day;
- Subject understands and is willing, able and likely to comply with all study procedures and restrictions;
- Subject is able to give voluntary oral and written informed consent, at the discretion of the investigator.
Exclusion
- Subjects with an elevated INR (INR\> 1.2) at screening visit;
- No gastrointestinal bleeding history within 12 months prior to screening visit;
- No history of endoscopically proven peptic ulcer disease;
- Known hypersensitivity to warfarin;
- Prosthetic heart valves, mitral stenosis, or other conditions such as recent (\<3 months) pulmonary embolism requiring anticoagulant therapy;
- History or presence of renal and hepatic insufficiency;
- History of hyperthyroidism;
- History of any bleeding disorder or hypercoagulation state;
- Surgical or medical condition liable to interfere with the absorption, metabolism or excretion of warfarin;
- Regular intake of other medication affecting the process of coagulation or platelet aggregation (during the 2 weeks prior to screening and/or during the run-in and treatment periods);
- Significant change in diet likely to interfere with the effects of warfarin in the 2 weeks prior to screening and/or during the run-in and treatment periods, at the discretion of the investigator;
- History of conditions associated with hemorrhagic risk, surgery or head injury within 6 months prior to screening visit;
- Hematological abnormalities (thrombocytopenia, clinically significant low granulocyte count, anemia, hypofibrinogenaemia, hemophilia, purpura, hemopathy with prolongation of bleeding time);
- Blood loss/donation \>400 mL within 12 weeks prior to the screening visit and/or during the run-in and treatment periods;
- Known to have serum hepatitis or who are carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody, or have a positive result to the test for HIV antigens and/or antibodies;
- Pregnancy or lactation;
- Participation in any other clinical trial or receipt of an investigational drug within 60 days prior to the time of the screening visit, or previous participation in this study;
- Those subjects unable, in the opinion of the investigator, to comply fully with the trial requirements;
- Subjects with a recent history (within 24 months prior to the screening visit) of alcoholism or known drug dependence, at the discretion of the investigator;
- Subjects with positive urine cotinine, urine drug screen and/or alcohol breath test;
- In the opinion of the investigator, patients with medical history or other factors which may interfere with enrollment or the study.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01475279
Start Date
July 1 2011
End Date
January 1 2012
Last Update
November 8 2012
Active Locations (1)
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1
Healthcare Discoveries, LLC d/b/a ICON Development Solutions
San Antonio, Texas, United States, 78209