A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

Study Overview
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Brief Summary
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A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

Detailed Description
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A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Official Title
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Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Conditions
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Hypertension, Dyslipidemias

Intervention / Treatment
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* Drug: CKD-348 F1
* Drug: CKD-348 F2
* Drug: CKD-828, D097, D337


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult volunteers aged ≥ 19-year-old Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2 Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests Those who agree to contraception during the participation of clinical trial Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month Those who has a history of gastrointestinal surgery ( Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests Women who are pregnant or who may be pregnant and breastfeed

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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>Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|
| Experimental: Sequence 2<br>Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|
| Experimental: Sequence 3<br>Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|
| Experimental: Sequence 4<br>Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|
| Experimental: Sequence 5<br>Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|
| Experimental: Sequence 6<br>Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions | Drug: CKD-348 F1<br>* QD, PO<br>Drug: CKD-348 F2<br>* QD, PO<br>Drug: CKD-828, D097, D337<br>* QD, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of CKD-348 | AUCt: Area under the concentration-time curve from time zero to time | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| Cmax of CKD-348 | Cmax: Maximum plasma concentration of the drug | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of CKD-348 | AUCinf: Area under the concentration-time curve from zero up to ∞ | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| Tmax of CKD-348 | Tmax: Time to maximum plasma concentration | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| t1/2 of CKD-348 | t1/2: Terminal elimination half-life | Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 
| AUCt/AUCinf of CKD-348 | AUCt/AUCinf | Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-348