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| Name | Class |
|---|---|
| Metro Hospital | UNKNOWN |
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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
30 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP1906 Tab. 5 mg" by cross-over design on day 1, 8.
Subjects in group 2 will be administered "YHP1906 Tab. 5 mg" and "comparator" by cross-over design on day 1, 8
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | 15 subjects, Cross-over, Single dose of comparator on day 1, Single dose of YHP1906 on day 8 |
|
| Group 2 | Other | 15 subjects, Cross-over, Single dose of YHP1906 on day 1, Single dose of comparator on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP1906 | Drug | YHP1906 Tab. 5 mg |
| |
| YHR1902 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Apixaban | 0-36 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of Apixaban | 0-36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Apixaban | 0-36 hours |
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sungdae Kwon | Metro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro Hospital | Anyang-si | Gyeonggi-do | 14096 | South Korea |
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| Drug |
Comparator. YHR1902 Tab. 5 mg |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Apixaban |
| 0-36 hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Apixaban | 0-36 hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Apixaban | 0-36 hours |