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Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet

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ClinicalTrials.gov Identifier: NCT02589457
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: CKD-390 Drug: Viread® tablet Phase 1

Detailed Description:
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Viread® tablet
Tenofovir Disoproxil Fumarate
Drug: Viread® tablet
Tenofovir Disoproxil Fumarate 1T PO

Experimental: CKD-390
Tenofovir Disoproxil Fumarate
Drug: CKD-390
Tenofovir Disoproxil Aspartate 1T PO




Primary Outcome Measures :
  1. AUCt of Tenofovir [ Time Frame: 0(Pre-dose) up to 72hr ]

Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 0(Pre-dose) up to 72hr ]
  2. Blood pressure [ Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day ]
  3. tmax [ Time Frame: 0(Pre-dose) up to 72hr ]
  4. t1/2β [ Time Frame: 0(Pre-dose) up to 72hr ]
  5. Clearance/F [ Time Frame: 0(Pre-dose) up to 72hr ]
  6. Electrocardiography [ Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day ]
  7. Physical Examination [ Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day ]
  8. Pulse rate [ Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day ]
  9. Temperature [ Time Frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy male volunteer in the age of 19-45
  2. Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20%
  3. Subject without a hereditary problems, chronic disease and morbid symptom
  4. Subject who sign on an informed consent form willingly

Exclusion Criteria:

  1. Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
  2. Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy)
  3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives
  4. Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
  5. Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
  6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
  7. Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
  8. The history of drug abuse or drug abuse showed a positive for urine drug test
  9. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month
  10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
  11. Taking drugs have received any other investigational drug within 3 months prior to the first dosing
  12. Whole blood donation within 2 months prior to the first dosing or component blood donation within 1 months prior to the first dosing or blood transfusion within 1 month
  13. Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge
  14. Cigarette > 10 cigarettes a day on average for recent 3 months
  15. Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
  16. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

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): NCT02589457


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Jung-gu, Korea, Republic of, 301-721
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Jang Hee Hong, MD, PhD Chungnam National University Hospital

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02589457     History of Changes
Other Study ID Numbers: 163BE15028
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by Chong Kun Dang Pharmaceutical:
Chronic Hepatitis B virus, HIV-1 infection
Healthy Male Volunteer
Tenofovir Disoproxil Fumarate
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents