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The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers
Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 2 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 3 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 4 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. | Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours) |
| AUCÏ„,ss | Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. | Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MinSoo Kim | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Severance Hospital | Seoul | South Korea |
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| Group 5 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
|
| Group 6 | Other | Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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| Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3) | Drug | Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration |
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