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Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858725
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: D569 Tab. Drug: CKD-374 5mg Tab. Phase 1

Detailed Description:

To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer
Actual Study Start Date : February 26, 2019
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D569/CKD-374 5mg
  1. Period 1: D569 Tab. 1T
  2. Period 2: CKD-374 5mg Tab. 1T
Drug: D569 Tab.
D569 Tab. 1T single oral administration under fasting condition

Drug: CKD-374 5mg Tab.
CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition

Experimental: CKD-374 5mg/D569
  1. Period 1: CKD-374 5mg Tab. 1T
  2. Period 2: D569 Tab. 1T
Drug: D569 Tab.
D569 Tab. 1T single oral administration under fasting condition

Drug: CKD-374 5mg Tab.
CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition




Primary Outcome Measures :
  1. AUCt of CKD-374 and D569 [ Time Frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours] ]
    Area under the CKD-374/ D569 concentration in blood-time curve from zero to final

  2. Cmax of CKD-374 and D569 [ Time Frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours] ]
    The maximum CKD-374/ D569 concentration in blood sampling time t



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Ages Eligible for Study:   19 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subject older than 19 years and less than 55 years at the screening
  2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5kg/m2 and a total body weight ≥ 55 kg

    * BMI = Weight(kg)/ Height(m)2

  3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
  4. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG, chest X-ray etc.)
  5. Individuals who signed an informed consent form approved by the 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. Individuals with the ability and willingness to participate during the study period

Exclusion Criteria:

  1. Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
  2. Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
  3. Individuals with the following laboratory test results: ALT or AST > 2x the upper limit of the normal range
  4. A history of regular alcohol consumption exceeding 210 g/week within the 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
  5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
  6. Individuals who had been administered investigational product(s) of other clinical study or bioequivalence study within the 3 months prior to the first dose of this study
  7. Individuals with the following vital signs results at screening

    *Individuals who had sitting blood pressure ≥90 mmHg or <140 mmHg (systolic) or ≥90 mmHg or <60 mmHg (diastolic)

  8. Individuals with a medical history of significant alcohol abuse or drug abuse within one year prior to the screening
  9. Individuals 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 dose of investigational product(s)
  10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
  11. Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
  12. Individuals with severe acute/chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
  13. Individuals with hypersensitivity to ingredients used in the investigational product(s)
  14. Patients with serious infection (e.g., Sepsis) or active infection including localized infection or history of interstitial pneumonia
  15. Patients with active tuberculosis or history of tuberculosis
  16. Patients with hepatopathy
  17. Patients with an absolute neutrophil count (ANC) less than 1000 /ul
  18. Patients with an absolute lymphocyte count (ALC) less than 500 /ul
  19. Patients who have hemoglobin levels less than 9 g/dL
  20. Women who are pregnant or may be pregnant
  21. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  22. Patients with nephropathy (eGFR<60 ml/min/1.73 m2)
  23. Individuals 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): NCT03858725


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: Kyung-Ho Jang Chonbuk National University Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03858725    
Other Study ID Numbers: 190BE18031
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 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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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases