A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.

Official Title
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An Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 After Oral Administration in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: RLD2301
* Drug: RLD2007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 54 years in healthy volunteers 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial 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: 54 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (First RLD2301, then RLD2301+RLD2007)<br>Period1 : RLD2301 Period2 : RLD2301 + RLD2007 | Drug: RLD2301<br>* Take it once a day per period.<br>Drug: RLD2007<br>* Take it once a day per period.<br>|
| Experimental: Arm 2 (First RLD2007, then RLD2301+RLD2007)<br>Period1 : RLD2007 Period2 : RLD2301 + RLD2007 | Drug: RLD2301<br>* Take it once a day per period.<br>Drug: RLD2007<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 |
| --- | --- | --- |
| AUCtau | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Css,max | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Css,min | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Css,av | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Tss,max | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| t1/2 | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| CLss/F | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Vdss/F | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Fluctuation[(Css,max-Css,min)/Css,av] | Pharmacokinetic evaluation | 0 24 hours after final dose administration | 
| Swing[(Css,max-Css,min)/Css,min] | Pharmacokinetic evaluation | 0 24 hours after final dose administration |