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This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.
This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.
Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8.
Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | taking YHD1119 (pregabalin 300mg) in fasted state at Period 1 |
|
| Group2 | Experimental | taking YHD1119 (pregabalin 300mg) in fed state at Period 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHD1119 300mg | Drug | Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| YHD1119 Cmax | Cmax | 0 - 36hrs |
| YHD1119 AUC last | AUC last | 0 - 36hrs |
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Inclusion Criteria:
Exclusion Criteria:
Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Mingul Kim, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34256964 | Derived | Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11. |
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A randomized, open-label, single dose, cross-over clincial trial
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| YHD1119 300mg | Drug | Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition |
|