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Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Active Comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
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| Sequence B | Active Comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
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| Sequence C | Active Comparator | CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828, D097, D337, CKD-348 T1, CKD-348 T2 | Drug | Subject of sequence A takes IP in the following order:
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration of the drug | 0 hour ~ 144 hr |
| AUCt | Area under the concentration time curve from time zero to time | 0 hour ~ 144 hour |
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Inclusion Criteria:
Exclusion Criteria:
1. Subject who cannot participate in a clinical trial based on the PI's judgment
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| Name | Affiliation | Role |
|---|---|---|
| Jae Yong Chung | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
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| CKD-348 T1, CKD-348 T2, CKD-828, D097, D337, | Drug | Subject of sequence B takes IP in the following order:
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| CKD-348 T2, CKD-348 T1, CKD-828, D097, D337 | Drug | Subject of sequence C takes IP in the following order:
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