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This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers
This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group 1 | Experimental | Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601) |
|
| Sequence Group 2 | Experimental | Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1601 | Drug | Test Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours | pharmacodynamic evaluation | 7Day 24h(Full time) pH monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| Cmax of esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time | exploratory endpoint | 1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujin Kim, Pharm.D. | Contact | +821065589053 | sjk9053@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| HGP1705 | Drug | Reference Drug |
|
|
pharmacokinetic evaluation
| 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| Tmax of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| Terminal Half-life of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| CL/F of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| Vd/F of esomeprazole | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| Ctrough | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour |
| Ctrough,ss | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| PTF | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| RActrough | pharmacokinetic evaluation | 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour |
| After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours | pharmacodynamic evaluation | 1Day 24h pH monitoring |
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | pharmacodynamic evaluation | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | pharmacodynamic evaluation | 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring |
| After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours | pharmacodynamic evaluation | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h |
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours | pharmacodynamic evaluation | 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h |
| After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours | pharmacodynamic evaluation | 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |