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A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1802 | Drug | Test drug |
| |
| HGP1705 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | 0-24hours | |
| Reduced rate from baseline in 24h integrated gastric pH | 0-24hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 0-24hours | |
| Tmax | 0-24hours | |
| t1/2 | 0-24hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39289057 | Derived | Kim Y, Bae S, Jeon I, Kwon J, Hong SH, Kim NY, Yu KS, Jang IJ, Lee S. Pharmacokinetics and Pharmacodynamics of a Fixed-Dose Combination of Esomeprazole and Magnesium Hydroxide Compared to the Enteric-Coated Esomeprazole. Clin Ther. 2024 Nov;46(11):870-876. doi: 10.1016/j.clinthera.2024.08.006. Epub 2024 Sep 16. |
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| Drug |
Reference drug |
|
| CL/F | 0-24hours |
| Vd/F | 0-24hours |
| AUCtau | 0-24hours |
| Cmin,ss | 0-24hours |
| Cmax,ss | 0-24hours |
| t1/2,ss | 0-24hours |
| CLss/F | 0-24hours |
| Vd,ss/F | 0-24hours |
| Reduced rate from baseline in 24h integrated gastric pH | 0-24hours |
| Duration time with integrated gastric pH>4 / 24hr | 0-24hours |
| Median 24 hr gastric pH | 0-24hours |