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| Name | Class |
|---|---|
| Chonbuk National University Hospital | OTHER |
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A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers
32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.
Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Other | 16 subjects, Cross-over, Single dose of comparator on day1, Single dose of YHP1903 on day8 |
|
| Group2 | Other | 16 subjects, Cross-over, Single dose of YHP1903 on day1, Single dose of comparator on day8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP1903 | Drug | YHP1903 Tab. 1mg |
| |
| Champix |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | AUCt of Varenicline | 0-96 hours |
| Cmax | Cmax of Varenicline | 0-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | AUCinf of Varenicline | 0-96 hours |
| Tmax | Tmax of Varenicline | 0-96 hours |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant disease
Sitting blood pressure meeting the following criteria at screening:
Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit or Total bilirubin > 2.0 mg/dl at the time of screening
Volunteers considered not eligible for the clinical trial by the investigator
Administration of other investigational products within 6 month prior to the first dosing.
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim, PhD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk national university hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Comparator Champix Tab. 1mg |
|
| t1/2 | t1/2 of Varenicline | 0-96 hours |
| D011810 | Quinoxalines |