Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012

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-2011 and AD-2012 in healthy male volunteers.

Detailed Description
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To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Official Title
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An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers

Conditions
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Hyperlipidemias, Hypertension

Intervention / Treatment
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* Drug: AD-2011 10/20 mg
* Drug: AD-2012 80mg
* Drug: AD-2011 10/20 mg + AD-2012 80mg


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 between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2 Exclusion Criteria: Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery AST, ALT values over than 1.5 times of ULN at screening HDL values less than 35 mg/dL A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

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-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|
| Experimental: Sequence 2<br>Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|
| Experimental: Sequence 3<br>Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|
| Experimental: Sequence 4<br>Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|
| Experimental: Sequence 5<br>Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|
| Experimental: Sequence 6<br>Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD | Drug: AD-2011 10/20 mg<br>* AD-2011 10/20 mg tablet<br>Drug: AD-2012 80mg<br>* AD-2012 80mg tablet<br>Drug: AD-2011 10/20 mg + AD-2012 80mg<br>* AD-2011 10/20 mg + AD-2012 80mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration | Cmax of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Area under the plasma concentration versus time curve | AUCtau of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach Cmax | Tmax of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Concentration | Ctrough of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Elimination half-life | t1/2 of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Clearance | CL/F of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Volume of distribution | Vd/F of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours | 
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 up to Day 45 |