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A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(N=10) | Other | Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 |
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| Group 2(N=10) | Other | Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 |
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| Group 3(N=10) | Other | Treatment A for Period I Treatment E Treatment D *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 |
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| Group 4(N=10) | Other | Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | JW0201: single administration, Tablet, Oral, BID for 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | Cmax,ss of each drug | up to 12hour(or 24hour) after administration |
| AUCÏ„,ss | AUCÏ„,ss of each drug | up to 12hour(or 24hour) after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin,ss | Cmin,ss of each drug | up to 12hour(or 24hour) after administration |
| Tmax,ss | Tmax,ss of each drug | up to 12hour(or 24hour) after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, PI | Jeonbuk National University Hospita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospita | Jeonju | Jeollabuk-do | 54907 | South Korea |
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A randomized, open-label, multiple-dose, 2x3 crossover clinical trial
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| Treatment B | Drug | C2103: single administration, Tablet, Oral, BID for 5 days |
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| Treatment C | Drug | JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days |
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| Treatment D | Drug | C2104 : single administration, Tablet, Oral, QD for 5 days |
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| Treatment E | Drug | JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days |
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| CLss/F | CLss/F of each drug | up to 12hour(or 24hour) after administration |
| Vdss/F | Vdss/F of each drug | up to 12hour(or 24hour) after administration |
| fluctuation | fluctuation of each drug | up to 12hour(or 24hour) after administration |