A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects

Study Overview
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Brief Summary
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An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.

Official Title
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A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults

Conditions
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Health, Subjective

Intervention / Treatment
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* Drug: HGP1810
* Drug: HCP1704


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 55 years in healthy volunteers BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2 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 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 Subjects who judged ineligible by the investigator

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>Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704 | Drug: HGP1810<br>* HGP1810: Vildagliptin/Metformin<br>Drug: HCP1704<br>* HCP1704: Vildagliptin/Metformin<br>|
| Experimental: Sequence 2<br>Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810 | Drug: HGP1810<br>* HGP1810: Vildagliptin/Metformin<br>Drug: HCP1704<br>* HCP1704: Vildagliptin/Metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| AUClast of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| Cmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| AUClast of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| Tmax of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| t1/2 of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| CL/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| Vd/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| AUCinf of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| Tmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| t1/2 of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| CL/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour | 
| Vd/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour |