A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects

Study Overview
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Brief Summary
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To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.

Official Title
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A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects

Conditions
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Dyslipidemias, Hypertension

Intervention / Treatment
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* Drug: Sequence 1
* Drug: Sequence 2
* Drug: Sequence 3
* Drug: Sequence 4
* Drug: Sequence 5
* Drug: Sequence 6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between ≥ 19 and ≤ 40 years old Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m² Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial Subject who agree not to provide sperm Subject who voluntarily agree to participate in this study Exclusion Criteria: Any medical history that may affect drug absorption, distribution, metabolism and excretion Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder Subject who have received other clinical trial drugs within 90 days prior to the screening visit Any clinically significant active chronic disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Sequence 1 | Drug: Sequence 1<br>* D326, D337 or CKD-828 for 9 days<br>|
| Experimental: Sequence 2<br>Sequence 2 | Drug: Sequence 2<br>* D326, D337 or CKD-828 for 9 days<br>|
| Experimental: Sequence 3<br>Sequence 3 | Drug: Sequence 3<br>* D326, D337 or CKD-828 for 9 days<br>|
| Experimental: Sequence 4<br>Sequence 4 | Drug: Sequence 4<br>* D326, D337 or CKD-828 for 9 days<br>|
| Experimental: Sequence 5<br>Sequence 5 | Drug: Sequence 5<br>* D326, D337 or CKD-828 for 9 days<br>|
| Experimental: Sequence 6<br>Sequence 6 | Drug: Sequence 6<br>* D326, D337 or CKD-828 for 9 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax(Maximum plasma concentration of the drug at steady state) | PK parameters of D326, D337 and CKD-828 | at Day 9 | 
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | PK parameters of D326, D337 and CKD-828 | at Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax(Time to maximum plasma concentration at steady state) | PK parameters of D326, D337 and CKD-828 | at Day 9 | 
| t1/2(Terminal elimination half-life) | PK parameters of D326, D337 and CKD-828 | at Day 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyslipidemias, hypertension, Drug-Drug interaction