Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D958 in Healthy Adults

Study Overview
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Brief Summary
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A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-341

Detailed Description
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A Randomized, Open-label, Oral, Single-dose, 2-treatment, Replicate crossover, 4-period Stuy

Official Title
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A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of D958 and CKD-341 in Healthy Adult Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-341, D958


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers, aged ≥ 19 years old at the time of screening Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 30.0 kg/m2 at the time of screening Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination According to the characteristics of the drug and Individuals who were deemed to be eligible based on the screening tests such as Clinical laboratory tests, vital signs, Physical examination, 12-lead electrocardiogram Before participating in the trial, the purpose and contents of the trial were fully explained, and the participants agreed to participate in this study voluntarily who signed Exclusion Criteria: Those with clinically significant diseases or history in liver, renal, neurological, psychiatric, respiratory, endocrine, tumor, urinary, cardiovascular, gastrointestinal, musculoskeletal system, etc or evidence one who has 1-1. Patients with biliary atresia and Severely liver dysfunction 1-2. Renal dysfunction 1-3. Shock patient 1-4. Patients with hypokalemia, hyponatremia and hypercalcemia 1-5. Addison's syndrome 1-6. Primary aldosteronism 1-7. Arterial valve/Mitral stenose or hypertrophic obstructive cardiomyopathy 1-8. Renovascular hypertension or anuria 1-9. Hypotension 1-10. Arteriosclerosis or cerebral arteriosclerosis 1-11. Patients with symptomatic hyperuricemia (history of gout or urolithiasis) or Patients with diabetes including family history 1-12. Hyperparathyroidism 1-13. Sympathectomy For female, pregnant female (Urine-human chorionic gonadotropin-positive) or lactating female Patients with hypersensitivity or a history of hypersensitivity to this drug or ingredients contained in this drug, dihydropyridine derivatives, thiazide diuretics, or sulfonamide drugs Patients receiving lithium therapy Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have a history of gastrointestinal surgery(crohn's disease, ulcer, acute/chronic pancreatitis) except simple appendectomy and hernia surgery(excluding appendicitis or hernia) which can interfere with drug absorption. Subjects with clinically significant findings including the following findings on 12-lead electrocardiogram at the time of screening corrected QT interval(QTc) > 450 ms for males, QTc > 470 ms for females Pulmonary Regurgitation(PR) interval > 200 ms QRS(QRS-complex) duration > 120 ms Subjects who shows the following results in a clinical laboratory test at the time of screening Aspartate aminotransferase (AST), Alanine aminotransferase(ALT), Alkaline phosphatase(ALP), γ-glutamyl transpeptidase(γ-GT) and Bilirubin total > 2 times higher than upper normal level Epidermal Growth Factor Receptor(eGFR) (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2 Creatine phosphokinase(CPK) > 2.5 times higher than upper normal level Those who has a drug abuse history within one year or positive reaction on urine drug screening test Under 5 min resting condition, systolic blood pressure >150 mmHg or or ≤ 90 mmHg, diastolic blood pressure ≥100 mmHg or <50 mmHg, pulse ≥100 bpm or ≤ 40 bpm Those who have administered drug metabolizing enzyme inducing or inhibiting drugs such as barbiturates within 1 month before the first administration date Those who eat abnormal diets that may affect the absorption, distribution, metabolism, and excretion of investigational drugs, or those who consume foods that may affect drug metabolism Cyclosporine, non-steroidal anti-inflammatory drugs, terfenadine, astemizole, digitalis, glucocorticosteroids, adrenocorticotropic hormone, and drugs affecting the renin-angiotensin-aldosterone system (RAAS) should be avoided within 2 weeks prior to the first dose. If you have administered any prescription drugs or herbal preparations that may affect the characteristics of clinical trial drugs, including a person who has administered any over-the-counter drug (OTC) or vitamin preparation within 10 days (However, if the drug does not affect the pharmacokinetic properties of the clinical trial drug, the investigator may participate in the clinical trial at the discretion of the investigator.) Those who participated in other clinical trials within 6 months prior to the first administration date and received administration (However, the criteria for termination of participation in other clinical trials is based on the last administration date and the next day is counted as 1 day.) Whole blood donation or component blood donation within 1 month before the first administration date, blood transfusion within 1 month, or those who cannot avoid blood donation from the time of written consent of the subject to the time of Post-visit study Those who have continuously consumed alcohol (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the first administration date or cannot abstain from drinking from the time of consent of the subject to the time of Post-visit study Smokers whose average smoking amount exceeds 10 cigarettes per day within 3 months prior to the first administration date and those who cannot quit smoking from 24 hours prior to administration in each period to the time of the last blood collection Those who have consumed food containing grapefruit (grapefruit) from 48 hours before the first administration to the time of Post-visit study or who cannot refrain from eating Those who consumed caffeine-containing foods (coffee, green tea, black tea, carbonated beverages, coffee milk, nutritional tonic drinks, etc.) from 24 hours before administration to the last blood sampling, or who could not refrain from taking them. During the period from 48 hours before the first administration to the time of Post-visit study, those who have performed strenuous exercise that exceeds the level of daily life or who cannot refrain from strenuous exercise From the time of consent of the subject until 2 weeks after the date of the last clinical drug administration, reliable methods of contraception (e.g., contraceptive administration and implantation or intrauterine device, sterilization procedure (vasectomy) A person who is not using an excision, tubal ligation, etc.) or blocking method (combined use of spermicide with condom, vaginal diaphragm for contraception, vaginal sponge, or cervical cap) Those who are judged by the principal investigator for reasons other than the above selection/exclusion criteria and are judged unsuitable for participation in this study

Ages Eligible for Study
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Minimum Age: 19 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 A<br>Period 1: D958 Period 2: CKD-341 Period 3: D958 Period 4: CKD-341 | Drug: CKD-341, D958<br>* A single dose of 1tablet under fasting condition<br>|
| Experimental: Sequence B<br>Period 1: CKD-341 Period 2: D958 Period 3: CKD-341 Period 4: D958 | Drug: CKD-341, D958<br>* A single dose of 1tablet under fasting condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under curve(AUC) of CKD-341, D958 | Area under the CKD-341, D958 concentration in blood-time curve from zero to final | Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours | 
| Cmax of CKD-341, D958 | The maximum CKD-341, D958 concentration in blood sampling time | Pre-dose(0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 144 hours |