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This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.
The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: DWP16001 A mg | Experimental |
| |
| Intervention: DWC202010 B mg | Experimental |
| |
| Intervention: DWP16001 A mg + DWC202010 B mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP16001 | Drug | DWP16001 A mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax,ss) of DWP16001 | Before IP administration of Day 1, Day 5, and Day 6 | |
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 | Before IP administration of Day 1, Day 5, and Day 6 | |
| Peak Plasma Concentration (Cmax,ss) of DWC202010 | Before IP administration and post-dose up to 24 hours | |
| Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 | Before IP administration and post-dose up to 24 hours |
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Inclusion Criteria:
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37593838 | Derived | Yoon S, Park MS, Jin BH, Shin H, Na J, Huh W, Kim CO. Pharmacokinetic and pharmacodynamic interaction of DWP16001, a sodium-glucose cotransporter-2 inhibitor, with phentermine in healthy subjects. Expert Opin Drug Metab Toxicol. 2023 Jul-Dec;19(7):479-485. doi: 10.1080/17425255.2023.2249397. Epub 2023 Aug 25. |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
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| DWP202010 | Drug | DWP202010 B mg |
|