Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Detailed Description
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To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Official Title
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A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

Conditions
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Hypertension

Intervention / Treatment
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* Drug: AD-2101
* Drug: AD-2102
* Drug: AD-2101 + AD-2102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male between 19 and 50 years of age at the time of screening Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 Exclusion Criteria: Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery A person who has a history of drug abuse AST, ALT, Total bilirubin values over than 2 times of UNL at screening Creatinine clearance under 80mL/min

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|
| Experimental: Sequence 2<br>Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|
| Experimental: Sequence 3<br>Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|
| Experimental: Sequence 4<br>Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|
| Experimental: Sequence 5<br>Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|
| Experimental: Sequence 6<br>Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101 | Drug: AD-2101<br>* AD-2101 16/5mg<br>Drug: AD-2102<br>* AD-2102 25mg<br>Drug: AD-2101 + AD-2102<br>* AD-2101 16/5mg + AD-2102 25mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration | Cmax,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours | 
| Area under the plasma concentration versus time curve | AUCt,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach Cmax | Tmax,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours | 
| Clearance | CLss/F of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours | 
| Bottom Plasma Concentration | Cmin,ss of the total ingredient of AD-2101 and AD-2102 | pre-dose to 24 hours | 
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 up to Day 66 |