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To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL-TOF tab. 5mg | Experimental | Tofacitinib freebase |
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| Xeljanz tab. 5mg | Active Comparator | Tofacitinib citrate (5mg as tofacitinib) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL-TOF tab. 5mg | Drug | HL-TOF |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration | 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour |
| AUC | Area under curve | 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Number of participants with adverse events | 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JAEWOO KIM | H Plus Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YANGJI Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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2X2
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| Xeljanz tab. 5mg | Drug | Xeljanz |
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