Clinical Trial to Evaluate Pharmacokinetic Profiles and Safety Between CKD-385 and D935 in Healthy Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, fed, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers

Detailed Description
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To healthy subjects of 52, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Official Title
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A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: D935 Cap. 1T
* Drug: CKD-385 Tab. 1T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy adult aged over 19 at the time of screening Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m² Subject who has no congenital or chronic disease within the last 3 years and no medical symptoms or signs as a result of medical examination Suitable subject who is determined at the time of screening by examiners according to the characteristics of the medicine such as hematology test, blood chemistry test, urine test, virus / bacteriological test, vital signs, electrocardiogram test Subject who signed the written consent form approved by Chonbuk National University Hospital IRB to participate in this study with full understanding of the purpose and contents of the examination prior to participation of the clinical trial Subject who has the ability and willingness to participate in the clinical trial Exclusion Criteria: Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.) Subject with a history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug Subject who shows the following values as a result of laboratory tests *ALT or AST > 2 times upper limit of normal range Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening Subject who smokes more than one pack of cigarette a day within 6 months of screening Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug Subject who conform to the specific items below systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position Severe bradycardia (less than 50 beats/minute) Subject who has significant alcohol abuse or drug abuse within a year of screening Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug. Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself. Subject who does not consent to reliable contraception during the entire period of clinical trial and until 7th day of administration of clinical trial drug. Subject who is not able to consume high-fat meal provided during the clinical trial Any other subject who is decided by investigators to be ineligible in clinical trial

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 |
| --- | --- |
| Active Comparator: Group 1<br>D935 Cap. 1T | Drug: D935 Cap. 1T<br>* single oral administration under fed condition<br>* Other names: D935;|
| Experimental: Group 2<br>CKD-385 Tab. 1T | Drug: CKD-385 Tab. 1T<br>* single oral administration under fed condition<br>* Other names: CKD-385;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Carvedilol | Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 
| Cmax of Carvedilol | Maximum plasma concentration of Carvedilol | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Carvedilol | Area under the plasma concentration of Carvedilol versus time curve from time zero to time infinity | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 
| Tmax of Carvedilol | Time to maximum concentration of Carvedilol | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 
| t1/2 of Carvedilol | Terminal elimination half-life of Carvedilol | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 
| CL/F of Carvedilol | Total body clearance of Carvedilol | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 
| Vd/F of Carvedilol | Apparent volume of distribution of Carvedilol | Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Chronic stable angina, Congestive Heart Failure