A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 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 HIP1701 in healthy subjects.

Official Title
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A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults

Conditions
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Health, Subjective

Intervention / Treatment
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* Drug: HIP1701
* Drug: HGP1809


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 + HIP1701, Period 2 : Fasted state + HGP1809 | Drug: HIP1701<br>* Vildagliptin<br>Drug: HGP1809<br>* Vildagliptin<br>|
| Experimental: Sequence 2<br>Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701 | Drug: HIP1701<br>* Vildagliptin<br>Drug: HGP1809<br>* Vildagliptin<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), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 
| AUClast of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 
| Tmax of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 
| t1/2 of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 
| CL/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour | 
| Vd/F of Vildagliptin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour |