Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

Study Overview
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Brief Summary
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The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly

Official Title
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An Open-labeled, Randomized Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Single Oral Administration of HGP0918 and HGP0816 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HGP0918
* Drug: HGP0816
* Drug: HGP0918 + HGP0816


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Healthy male volunteers, aged 19 to 55 years. The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2 Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>HGP0918 -> HGP0816 -> HGP0918 + HGP0816 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |
| Experimental: Sequence 2<br>HGP0816 -> HGP0918 + HGP0816 -> HGP0918 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |
| Experimental: Sequence 3<br>HGP0918 + HGP0816 -> HGP0918 -> HGP0816 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |
| Experimental: Sequence 4<br>HGP0918 -> HGP0918 + HGP0816 -> HGP0816 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |
| Experimental: Sequence 5<br>HGP0816 -> HGP0918 -> HGP0918 + HGP0816 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |
| Experimental: Sequence 6<br>HGP0918 + HGP0816 -> HGP0816 -> HGP0918 | Drug: HGP0918<br> <br> Drug: HGP0816<br> <br> Drug: HGP0918 + HGP0816<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline-corrected Cmax of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| baseline-corrected AUCt of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| Cmax of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| AUCt of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| AUCt of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| Tmax of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| t1/2β of HGP0918 |  | -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16) | 
| AUC∞ of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| Tmax of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| t1/2β of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| CL/F of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) | 
| Vdz/F of HGP0816 |  | 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13) |