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Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083872
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
This study is a randomized, open-label, fasting, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Reference drug Drug: Test drug Phase 1

Detailed Description:

To 16 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D744 Test drug: CKD-385 64 mg formulation I Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fasting Conditions
Actual Study Start Date : September 6, 2019
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: Group 1
  1. Period 1: Reference drug
  2. Period 2: Test drug
Drug: Reference drug
D744 Cap. 1 Cap., single oral administration under fasting condition
Other Name: D744

Drug: Test drug
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition
Other Name: CKD-385 64 mg formulation I

Experimental: Group 2
  1. Period 1: Test drug
  2. Period 2: Reference drug
Drug: Reference drug
D744 Cap. 1 Cap., single oral administration under fasting condition
Other Name: D744

Drug: Test drug
CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition
Other Name: CKD-385 64 mg formulation I




Primary Outcome Measures :
  1. Area Under Curve last(AUCt) [ Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours ]
    Area under the plasma concentration time curve of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744, from time zero up to the last measurable concentration.

  2. Cmax [ Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours ]
    The maximum concentration observed of CKD-385 64 mg formulation Ⅰ/D744 or CKD-385 64 mg formulation Ⅱ/D744 over blood sampling time.



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. Healthy adult aged over 19 at the time of screening
  2. Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) < 30.5kg/m² and a total body weight ≥ 55 kg

    # BMI=Weight(kg) / Height(m)²

  3. Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  4. Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
  5. Subject who signed an informed consent form approved by the Institutional Review Board(IRB) of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
  6. Subject who must consent to the use of reliable contraception and not to donate sperm, from the 1st administration of the investigational product until 1 month after the last administration of investigational product
  7. Subject with the ability and willingness to participate during the study period

Exclusion Criteria

  1. Subject who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases
  2. Subject with a medical 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

    *Alanine Transaminase(ALT) or Aspartate Transaminase(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 prior to screening
  5. Subject who smokes more than 20 cigarettes a day within 6 months prior to screening
  6. Subject who took other clinical trial drugs or bioequivalence test drugs within 6 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, not less than 140 mmHg or diastolic blood pressure less than 60 mmHg or not less than 90 mmHg in a sitting position
    • Severe bradycardia (less than 50 beats/minute)
  8. Subject who has a medical history of significant alcohol abuse or drug abuse within one year prior to screening
  9. Subject who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first administration of investigational product(s).
  10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of investigational product(s).
  11. Subject who donated whole blood within 2 months, or blood components within 1 month prior to first administration of investigational product(s).
  12. Subject who has hypersensitivity to investigational product(s) or investigational product(s) ingredient.
  13. Subject who were deemed to be inappropriate to participate in the study by the investigator.

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): NCT04083872


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Min-gul Kim Chonbuk National University Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04083872    
Other Study ID Numbers: A88_05BE1912P
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
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
Additional relevant MeSH terms:
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Cardiovascular Diseases