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This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive days. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. |
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| 2 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. |
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| 3 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. |
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| 4 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1706 QD for 6 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 3. There will be a washout of at least 10 days between the last dose in one period and the first dose in the subsequent period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHR1705 | Drug | Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period. |
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| Measure | Description | Time Frame |
|---|---|---|
| YHR1705, YHR1706 AUCtau | AUCtau | 0 - 24hours |
| YHR1705, YHR1706 Css, max | Css,max | 0 - 24hours |
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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 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| 5 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 3. |
|
| 6 | Experimental | 5 subjects will be assigned In this group. Subjects will receive multiple oral doses of YHR1705+YHR1706 QD for 5 consecutive days during period 1. Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days during period 2. Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days during period 3. |
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| YHR1706 | Drug | Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period. |
|
| YHR1705+YHR1706 | Drug | Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period. |
|
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |