Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Primary endpoint:
•The change in INR with T89 (Day 25) compared with that without T89 (Day 18)
Secondary endpoints:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin; Dantonic | Drug | Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24 | 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. | outcome measure will be assessed in two weeks and data will be presented up to eight weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, LLC d/b/a ICON Development Solutions | San Antonio | Texas | 78209 | United States |
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| C581239 | T89 herbal drug |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |