Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012

Study Overview
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Brief Summary
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To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers

Detailed Description
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Pharmacokinetic endpoints Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan Safety evaluation Adverse reactions (but only in case of TEAE) Concomitant drugs Vital signs Laboratory test

Official Title
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A Phase I Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Drug: ATB-101, ATB-1011, ATB-1012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who are over 19 years old at the screening visit Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit Those who determined as suitable study subjects by the principal investigator A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial Exclusion Criteria: Those who have a clinically significant disease or have a history of such disease Those who have a history of gastrointestinal surgery Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date. Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date

Ages Eligible for Study
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Minimum Age: 19 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
Interventional Model Description: Open, Randomization, single oral administration, 2 Intervention group, crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequence A=Reference-Test<br>T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012 First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose | Drug: ATB-101, ATB-1011, ATB-1012<br>* Test drug - Code name: ATB-101 Control drug1 Code name: ATB-1011 Active ingredient: Olmesartan Control drug2 Code name: ATB-1012 Active ingredient: Dapagliflozin<br>* Other names: ATB-1012 brand name: Forxiga;|
| Active Comparator: Sequence B=Test-Reference<br>First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose | Drug: ATB-101, ATB-1011, ATB-1012<br>* Test drug - Code name: ATB-101 Control drug1 Code name: ATB-1011 Active ingredient: Olmesartan Control drug2 Code name: ATB-1012 Active ingredient: Dapagliflozin<br>* Other names: ATB-1012 brand name: Forxiga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Olmesartan | Area under the concentration-time curve | Day1(first stage), Day8(scond stage) | 
| Cmax of Olmesartan | Maximum concentration of drug in plasma | Day1(first stage), Day8(scond stage) | 
| AUCt of Dapagliflozin | Area under the concentration-time curve | Day1(first stage), Day8(scond stage) | 
| Cmax of Dapagliflozin | Maximum concentration of drug in plasma | Day1(first stage), Day8(scond stage) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC∞ of Olmesartan | Area under the plasma drug concentration-time curve from time 0 to infinity | Day1(first stage), Day8(scond stage) | 
| Tmax of Olmesartan | Time to maximum plasma concentration | Day1(first stage), Day8(scond stage) | 
| T1/2 of Olmesartan | Terminal elimination half-life | Day1(first stage), Day8(scond stage) | 
| CL/F of Olmesartan | Apparent total clearance of the drug from plasma after oral administration | Day1(first stage), Day8(scond stage) | 
| Vd/F of Olmesartan | Apparent volume of distribution after non-intravenous administration | Day1(first stage), Day8(scond stage) | 
| AUC∞ of Dapagliflozin | Area under the plasma drug concentration-time curve from time 0 to infinity | Day1(first stage), Day8(scond stage) | 
| Tmax of Dapagliflozin | Time to maximum plasma concentration | Day1(first stage), Day8(scond stage) | 
| T1/2 of Dapagliflozin | Terminal elimination half-life | Day1(first stage), Day8(scond stage) | 
| CL/F of Dapagliflozin | Apparent total clearance of the drug from plasma after oral administration | Day1(first stage), Day8(scond stage) | 
| Vd/F of Dapagliflozin | Apparent volume of distribution after non-intravenous administration | Day1(first stage), Day8(scond stage) |