A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Study Overview
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Brief Summary
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A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Detailed Description
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An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Official Title
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An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Conditions
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Dyslipidemias, Hypertension

Intervention / Treatment
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* Drug: D013, D326 and D337
* Drug: D013
* Drug: D326 and D337


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between ≥ 20 and ≤ 45 years old Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m² Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study Exclusion Criteria: History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration Any medical history that may affect drug absorption, distribution, metabolism and excretion Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder Any clinically significant active chronic disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Part A, Sequence1<br>Period 1: Treatment of D013, D326 and D337 on Day1 Day7 Period 2: Treatment of D013 on Day22 Day28 | Drug: D013, D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Test;Drug: D013<br>* Daily oral administration of 1 tablet under fasting conditions for 7 days<br>* Other names: CKD-386 Reference1;|
| Experimental: Part A, Sequence 2<br>Period 1: Treatment of D013 on Day1 Day7 Period 2: Treatment of D013, D326 and D337 on Day22 Day28 | Drug: D013, D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Test;Drug: D013<br>* Daily oral administration of 1 tablet under fasting conditions for 7 days<br>* Other names: CKD-386 Reference1;|
| Experimental: Part B, Sequence 1<br>Period 1: Treatment of D013, D326 and D337 on Day1 Day7 Period 2: Treatment of D326 and D337 on Day22 Day28 | Drug: D013, D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Test;Drug: D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Reference2;|
| Experimental: Part B, Sequence 2<br>Period 1: Treatment of D326 and D337 on Day1 Day7 Period 2: Treatment of D013, D326 and D337 on Day22 Day28 | Drug: D013, D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Test;Drug: D326 and D337<br>* Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days<br>* Other names: CKD-386 Reference2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| Cmax,ss(Maximum plasma concentration of the drug at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmin,ss(Minimum concentration of the drug in plasma at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| Tmax,ss(Time to maximum plasma concentration at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| t1/2(Terminal elimination half-life) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| CLss/F(Apparent total body clearance of the drug from plasma at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| Vd,ss/F(Apparent volume of distribution at steady state) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 
| PTF(Peak-to-trough fluctuation) | Part A: Pharmacokinetic parameter of D013 after multiple dosing Part B: Pharmacokinetic parameters of D326 and D337 after multiple dosing | 0(predose) 24 hours at Day7 and Day28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Dyslipidemia, CKD-386, Drug-Drug Interaction