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The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-P023 | Experimental | One tablet of HD-P023 by oral |
|
| Co-administration of Teneligliptin and Empagliflozin High | Active Comparator | One tablet each of Teneligliptin and Empagliflozin High by oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD-P023 | Drug | Single dose administration of HD-P023 |
| |
| Teneligliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin | 72 hours | |
| Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin | 72 hours | |
| Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital | Siheung-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| C570240 | empagliflozin |
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| Drug |
Single does administration of Teneligliptin and Empagliflozin High |
|
| Empagliflozin | Drug | Single does administration of Teneligliptin and Empagliflozin High |
|
| Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin | 72 hours |
| Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin | 72 hours |
| Clearance (CL/F) of Teneligliptin and Empagliflozin | 72 hours |