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
This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib, Moxifloxacin, Water in order | Experimental |
|
|
| Celecoxib, Water, Moxifloxacin in order | Experimental |
|
|
| Moxifloxacin, Water, Celecoxib in order | Experimental |
|
|
| Water, Moxifloxacin, Celecoxib in order | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Celecoxib 400mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in QTc interval, read manually | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QTc , measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JUNGRYUL KIM, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31564512 | Derived | Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000077266 | Moxifloxacin |
| D014867 | Water |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Moxifloxacin | Drug | Moxifloxacin 400mg tablet |
|
|
| Water | Other | Pure water 150ml |
|
| ventricular rate, measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
| PR duration, measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
| RR duration, measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
| QRS duration, measured automatically | which is analyzed at the date of initial and final administration of celecoxib, moxifloxacin, water toward healthy volunteers. | -1 hour, -40 minutes, -20 minutes pre-dose at initial administration day and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at last administration day |
| Area under the curve within a dosing interval at steady state | which is analyzed at the date of final administration of celecoxib | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6) |
| Maximum concentration at steady state | which is analyzed at the date of final administration of celecoxib | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6) |
| Time to maximum concentration at steady state | which is analyzed at the date of final administration of celecoxib | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6) |
| Minimum concentration at steady state | which is analyzed at the date of final administration of celecoxib | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day6) |
| Area under the concentration-time curve time zero to the time of the last quantifiable concentration | which is analyzed at the date of final administration of moxifloxacin | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1) |
| Maximum concentration | which is analyzed at the date of final administration of moxifloxacin | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1) |
| Time to maximum concentration | which is analyzed at the date of final administration of moxifloxacin | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1) |
| Half-life | which is analyzed at the date of final administration of moxifloxacin | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1) |
| The apparent clearance | which is analyzed at the date of final administration of moxifloxacin | 0 hour pre-dose and 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours post-dose at final administration day(Day1) |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |