A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
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|ClinicalTrials.gov Identifier: NCT01475279|
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : November 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Warfarin; Dantonic||Phase 1|
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 between Dantonic and warfarin on humans. It is highly relevant to investigate the potential interaction of theses two drugs.
•The change in INR with T89 (Day 25) compared with that without T89 (Day 18)
- The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24
- Safety assessments across all time points
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multiple-Dose, Single-Center, Sequential, Inpatient Study to Determine the Effect of T89 on Steady-State Pharmacodynamics of Warfarin in Healthy Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||January 2012|
- Drug: Warfarin; Dantonic
Individual warfarin dose during the study; 225mg Dantonic b.i.d for one weekOther Name: coumadin
- The change in INR with T89 (Day 25) compared with that without T89 (Day 18) [ Time Frame: outcome measure will be assessed in two weeks and data will be presented up to eight weeks ]The mean INR change with T89 (Day 25) and without T89 (Day 18) will be assessed by standard t test.
- The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24 [ Time Frame: outcome measure will be assessed in two weeks and data will be presented up to eight weeks ]The S- and R-warfarin concentration time profiles will be listed and displayed graphically. And 90% CI of the geometric mean ratio for Cmax and AUClast of both R- and S-warfarin will be caculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475279
|United States, Texas|
|Healthcare Discoveries, LLC d/b/a ICON Development Solutions|
|San Antonio, Texas, United States, 78209|