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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748212
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: D935 Cap. 1T Drug: CKD-385 Tab. 1T Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 in Healthy Volunteers
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
D935 Cap. 1T
Drug: D935 Cap. 1T
single oral administration under fed condition
Other Name: D935

Experimental: Group 2
CKD-385 Tab. 1T
Drug: CKD-385 Tab. 1T
single oral administration under fed condition
Other Name: CKD-385




Primary Outcome Measures :
  1. AUCt of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Area under the plasma concentration of Carvedilol verses time curve from time zero to time of last quantifiable concentration

  2. Cmax of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Maximum plasma concentration of Carvedilol


Secondary Outcome Measures :
  1. AUCinf of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Area under the plasma concentration of Carvedilol versus time curve from time zero to time infinity

  2. Tmax of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Time to maximum concentration of Carvedilol

  3. t1/2 of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Terminal elimination half-life of Carvedilol

  4. CL/F of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Total body clearance of Carvedilol

  5. Vd/F of Carvedilol [ Time Frame: Pre-dose(0hr), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48hrs ]
    Apparent volume of distribution of Carvedilol



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A healthy adult aged over 19 at the time of screening
  2. Weight over 55, with BMI between 17.5kg/m² and 30.5kg/m²
  3. 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
  4. 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
  5. 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
  6. Subject who has the ability and willingness to participate in the clinical trial

Exclusion Criteria:

  1. 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.)
  2. 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
  3. Subject who shows the following values as a result of laboratory tests

    *ALT or AST > 2 times upper limit of normal range

  4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
  5. Subject who smokes more than one pack of cigarette a day within 6 months of screening
  6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
  7. 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)
  8. Subject who has significant alcohol abuse or drug abuse within a year of screening
  9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
  10. 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.
  11. 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
  12. Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
  13. 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.
  14. Subject who is not able to consume high-fat meal provided during the clinical trial
  15. Any other subject who is decided by investigators to be ineligible in clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748212


Contacts
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Contact: Kyung-Ho Jang +82-63-259-3500 khjang@jbcp.kr
Contact: Min-Gul Kim mgkim@jbcp.kr

Locations
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Korea, Republic of
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Kyung-Ho Jang, Professor         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Kyung-Ho Jang Chonbuk National University Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03748212    
Other Study ID Numbers: 188BE18024
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Hypertension
Chronic stable angina
Congestive Heart Failure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases