The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.

Official Title
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A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: HIP2001
* Drug: HGP2001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug. Exclusion Criteria: A history of hypersensitivity reactions or clinically significant hypersensitivity reactions A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test Positive results of serological tests Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days Have drank more than 210 g/week of alcohol within 30 days before the screening date Have smoked more than 10 bills/day within 30 days before the screening date AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec 12-ECG QTc >450 ms

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 |
| --- | --- |
| Other: Sequence 1<br>Period 1: HGP2001, Period 2: HIP2001 | Drug: HIP2001<br>* Test drug<br>Drug: HGP2001<br>* Reference drug<br>|
| Other: Sequence 2<br>Period 1: HIP2001, Period 2: HGP2001 | Drug: HIP2001<br>* Test drug<br>Drug: HGP2001<br>* Reference drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | Pharmacokinetic evaluation | 0 48 hours | 
| Cmax | Pharmacokinetic evaluation | 0 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | Pharmacokinetic evaluation | 0 48 hours | 
| Tmax | Pharmacokinetic evaluation | 0 48 hours | 
| t1/2 | Pharmacokinetic evaluation | 0 48 hours | 
| CL/F | Pharmacokinetic evaluation | 0 48 hours | 
| Vd/F | Pharmacokinetic evaluation | 0 48 hours |