Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Detailed Description
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Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Official Title
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A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HGP1201
* Drug: HGP0904
* Drug: HGP0904 and HGP1201 co-administraion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteer, age 19 45 years The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2 Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study History of relevant drug allergies or clinically significant hypersensitivity reaction.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Group 1<br>A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |
| Experimental: Group 2<br>C → A → B | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |
| Experimental: Group 3<br>B → C → A | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |
| Experimental: Group 4<br>C → B → A | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |
| Experimental: Group 5<br>B → A → C | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |
| Experimental: Group 6<br>A → C → B | Drug: HGP1201<br> <br> Drug: HGP0904<br> <br> Drug: HGP0904 and HGP1201 co-administraion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of HGP1201, HGP0904 |  | 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h | 
| AUCτ,ss of HGP1201, HGP0904 |  | 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h |