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The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions
Pharmacokinetic characteristics: 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 |
|---|---|---|---|
| Sequence A | Other | Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration |
|
| Sequence B | Other | Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Drug or Test Drug | Drug | Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. | Day1 0h ~ Day4 72h |
| Cmax | Describes the blood concentration statistically by pharmacokinetic blood | Day1 0h ~ Day4 72h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeolJu Moon | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Jeonbuk National University Hospital | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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