A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin

NCT01475279 | Completed Phase 1 DMC

• 1 other identifier: T89-04-US
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 of Dantonic and warfarin.

Conditions

Healthy

Keywords

Warfarin; Dantonic; Pharmacodynamics; Pharmacokinetics; Interaction

Outcome Measures

Primary Outcomes (1)

• The change in INR with T89 (Day 25) compared with that without T89 (Day 18)

  The mean INR change with T89 (Day 25) and without T89 (Day 18) will be assessed by standard t test.

  outcome measure will be assessed in two weeks and data will be presented up to eight weeks

Secondary Outcomes (1)

• The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24

  outcome measure will be assessed in two weeks and data will be presented up to eight weeks

Interventions

Warfarin; Dantonic DRUG

Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week

Also known as: coumadin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Study Sites (1)

Healthcare Discoveries, LLC d/b/a ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

Warfarin; T89 herbal drug

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 21, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 8, 2012

Record last verified: 2011-11

Locations

US (1)