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The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.
[PART A] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302
[PART B] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [PART A] Sequence 1 | Experimental | Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302) |
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| [PART A] Sequence 2 | Experimental | Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302) |
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| [PART A] Sequence 3 | Experimental | Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306) |
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| [PART A] Sequence 4 | Experimental | Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306) |
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| [PART A] Sequence 5 | Experimental | Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1306 | Drug | Take it once a day per period. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCtau | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Css,max | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Css,min | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Css,av | Pharmacokinetic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-gul Kim, MD | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
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[PART A] 6 x 3 Crossover
[PART B] Single Arm (Three periods)
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| [PART A] Sequence 6 |
| Experimental |
Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302) |
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| [PART B] Single arm | Experimental | Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102) |
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| RLD2302 | Drug | Take it once a day per period. |
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| RLD2102 | Drug | Take it once a day per period |
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| [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Tss,max | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| t1/2 | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| CLss/F | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Vdss/F | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Fluctuation[(Css,max-Css,min)/Css,av] | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |
| Swing[(Css,max-Css,min)/Css,min] | Pharmacokinetic evaluation | [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration |