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The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.
Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other |
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| Group 2 | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A_Period 1 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Plasma concentrations are measured using a validated LC-MS/MS. | Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4 |
| Cmax | Plasma concentrations are measured using a validated LC-MS/MS. | Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Dae Kwon | Metro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metro Hospital | Anyang-si | Gyeonni-do | 14096 | South Korea |
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| Treatment B_Period 2 | Drug |
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| Treatment A_Period 3 | Drug |
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| Treatment B_Period 4 | Drug |
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| Treatment B_Period 1 | Drug |
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| Treatment A_Period 2 | Drug |
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| Treatment B_Period 3 | Drug |
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| Treatment A_Period 4 | Drug |
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| ID | Term |
|---|---|
| D012964 | Sodium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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