A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 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, safety and tolerability of HCP1801 in healthy subjects.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HCP1805
* Drug: HCP1801


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 45 years in healthy volunteers BMI is more than 18.5 kg/m^2 , no more than 29.9 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: 45 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 + HCP1805, Period 2 : Fasted state + HCP1801 | Drug: HCP1805<br>* Dapagliflozin/Metformin (Xigduo XR) 10/1000mg<br>Drug: HCP1801<br>* Dapagliflozin/Metformin 10/1000mg<br>|
| Experimental: Sequence 2<br>Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805 | Drug: HCP1805<br>* Dapagliflozin/Metformin (Xigduo XR) 10/1000mg<br>Drug: HCP1801<br>* Dapagliflozin/Metformin 10/1000mg<br>|
| Experimental: Sequence 3<br>Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 | Drug: HCP1805<br>* Dapagliflozin/Metformin (Xigduo XR) 10/1000mg<br>Drug: HCP1801<br>* Dapagliflozin/Metformin 10/1000mg<br>|
| Experimental: Sequence 4<br>Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 | Drug: HCP1805<br>* Dapagliflozin/Metformin (Xigduo XR) 10/1000mg<br>Drug: HCP1801<br>* Dapagliflozin/Metformin 10/1000mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| AUClast of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| Cmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| AUClast of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| Tmax of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| t1/2 of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| CL/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| Vd/F of Dapagliflozin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| AUCinf of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| Tmax of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| t1/2 of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| CL/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour | 
| Vd/F of Metformin | pharmacokinetic evaluation | pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour |