A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203

Study Overview
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Brief Summary
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The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects

Official Title
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An Open-label Phase 1 Study to Evaluate PK/PD Drug-drug Interactions and Safety/Tolerability Between RLD2202 and RLD2203 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: RLD2202
* Drug: RLD2203


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults in the age between 19 and 50 years old Body mass index (BMI) in the range of 18 to 27 kg/m2 and weight 50kg to 90kg. After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening. Subject who are eligible from physical examination, clinical laboratory test by investigators judgment. 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: 50 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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Sequence<br>Period 1: RLD2202, Period 2 : RLD2203 -> RLD2202+RLD2203 | Drug: RLD2202<br>* Take it once a day per period<br>Drug: RLD2203<br>* Take it once a day per period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of RLD2202 | Pharmacokinetic evaluation | 0 24 hours | 
| AUCtau,ss of RLD2202 | Pharmacokinetic evaluation | 0 24 hours | 
| Cmax,ss of RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| AUCtau,ss of RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| Inhibition of Platelet Aggregation(%) | Pharmacodynamic evaluation | 0 6 days | 
| Inhibition of Thromboxane B2(%) | Pharmacodynamic evaluation | 0 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax,ss of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| t1/2,ss of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| Cmin,ss of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| Cavg,ss of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| CLss/F of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| Vdss/F of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours | 
| PTF of RLD2202 and RLD2203 | Pharmacokinetic evaluation | 0 24 hours |