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A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337

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ClinicalTrials.gov Identifier: NCT03382756
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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Brief Summary:
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects

Condition or disease Intervention/treatment Phase
Dyslipidemias Dietary Supplement: High fat diet Drug: CKD-337 Phase 1

Detailed Description:

This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.

Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.

Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.

Each treatment period was separated by a washout period of at least 7 days.

Study Design
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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 Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 After a Single Oral Dose in Healthy Male Subjects
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 7, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A

Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition

Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition

 Dietary Supplement: High fat diet
A diet consisting of more than 900kcal and 35% of fat

Drug: CKD-337
Test Drug
Other Name: Atorvastatin Calcium Trihydrate + Choline Fenofibrate
Experimental: Group B

Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition

Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition

 Dietary Supplement: High fat diet
A diet consisting of more than 900kcal and 35% of fat

Drug: CKD-337
Test Drug
Other Name: Atorvastatin Calcium Trihydrate + Choline Fenofibrate


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-t of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration

  2. Cmax of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Maximum plasma concentration of Atorvastatin

  3. AUCt of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration

  4. Cmax of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Maximum plasma concentration of Fenofibric acid


Secondary Outcome Measures :
  1. AUCinf of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Area under the plasma concentration of Atorvastatin versus time curve from time zero to time infinity

  2. Tmax of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Time to maximum concentration of of Atorvastatin

  3. T 1/2 of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Apparent terminal half-life of Atorvastatin

  4. CL/F of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Total body clearance of Atorvastatin

  5. Vd/F of Atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Apparent volume of distribution of Atorvastatin

  6. AUCinf of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time infinity

  7. Tmax of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Time to maximum concentration of Fenofibric acid

  8. T 1/2 of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Apparent terminal half-life of Fenofibric acid

  9. CL/F of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Total body clearance of Fenofibric acid

  10. Vd/F of Fenofibric acid [ Time Frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration ]
    Apparent volume of distribution of Fenofibric acid

  11. AUC0-t of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time of last quantifiable concentration

  12. Cmax of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Maximum concentration attained of 2-hydroxy atorvastatin

  13. AUCinf of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time infinity

  14. Tmax of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Time to maximum concentration 2-hydroxy atorvastatin

  15. T 1/2 of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Apparent terminal half-life of 2-hydroxy atorvastatin

  16. CL/F of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Total body clearance of 2-hydroxy atorvastatin

  17. Vd/F of 2-hydroxy atorvastatin [ Time Frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration ]
    Apparent volume of distribution of 2-hydroxy atorvastatin


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects between the ages of 19 and 45 years
  2. Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
  3. Subject who doesn't have chronic disease, pathological symptoms or findings
  4. Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
  5. Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.

Exclusion Criteria:

  1. Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has medical histories listed below.

    • Gallbladder disease including cholelithiasis, severe hepatic impairment
    • Acute/chronic pancreatitis due to hypertriglyceridemia
    • Pulmonary embolism or interstitial lung disease
    • Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
    • Hypoalbuminemia
    • Alcoholics
    • Predisposition to rhabdomyolysis
  2. Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
  3. Subject who has hypersensitivity to the drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics

  4. Subject who has the following clinical significant findings in the EKG at the time of screening

    • QTc(Q-T interval corrected for heart rate) > 450ms
    • PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec
    • QRS duration(The duration of the QRS wave in ECG) > 120msec

  5. Subject whose results of the clinical laboratory tests are included in the following categories

    • CPK(Creatinine Phospho-Kinase) > 2x upper limit of normal range
    • Liver function test (AST;Aspartate Transaminase, ALT;Alanine Transaminase, ALP;Alkaline phosphatase, Total bilirubin, γ-GT;Gamma-Glutamyl Transferase) > 2 x upper limit of normal range
    • eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)
  6. Systolic blood pressure ≥ 160mmHg(millimeter of mercury) or ≤ 100mmHg(millimeter of mercury) , Diastolic blood pressure ≥ 95mmHg(millimeter of mercury) or ≤ 60mmHg(millimeter of mercury) at the time of screening
  7. History of drug abuse or a positive reaction for drug abuse examined by urinalysis at the time of screening
  8. Subject who took medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days prior to the first dose of medication
  9. Those who has experienced photoallergy or phototoxicity during treatment with fibrates or ketoprofen
  10. Subject who took ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days prior to the first dose of medication
  11. Subject who took the medication involved in other clinical trials within 3 months prior to the first dose of medication
  12. Subject who donated whole conducted blood donation within 2 months or component blood donation or blood transfusion within 1 month prior to the first dose of medication
  13. Subject who drinks alcohol more than 21 units per a week (1unit=10g of pure alcohol) continuously within 6 month prior to the first dose of medication or Who can not stop drinking alcohol during the clinical trial
  14. Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial
  15. Subject who consumed food containing grapefruit within 48 hours prior to the first dose of medication or who can not stop consumption it until EOS(End of study)
  16. Subject who consumed food containing caffeine(e.g. coffee, green tea etc.) within 24 hours prior to the first dose of medication or who can not stop consumption it until discharge
  17. Subject who do not use a reliable contraception or who plans a pregnancy during the clinical trial
  18. Subject who has unsuitable conditions decided by investigator's judgement including clinical laboratory result
Contacts and Locations
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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): NCT03382756


Locations
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Korea, Republic of
Dong-A University Hospital
Busan, Seo-gu, Korea, Republic of, 602-812
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Min Kyu Park, Professor Dong-A University Hospital
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03382756    
Other Study ID Numbers: 146FDI17001
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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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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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Atorvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Lipotropic Agents
Gastrointestinal Agents
Nootropic Agents