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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02589457
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
2
Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
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 :
Oct 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. AUCt of Tenofovir [0(Pre-dose) up to 72hr]

Secondary Outcome Measures

  1. AUCinf [0(Pre-dose) up to 72hr]

  2. Blood pressure [1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day]

  3. tmax [0(Pre-dose) up to 72hr]

  4. t1/2β [0(Pre-dose) up to 72hr]

  5. Clearance/F [0(Pre-dose) up to 72hr]

  6. Electrocardiography [1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day]

  7. Physical Examination [1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day]

  8. Pulse rate [1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day]

  9. Temperature [1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chungnam National University Hospital Daejeon Jung-gu Korea, Republic of 301-721

Sponsors and Collaborators

  • Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Jang Hee Hong, MD, PhD, Chungnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02589457
Other Study ID Numbers:
  • 163BE15028
First Posted:
Oct 28, 2015
Last Update Posted:
Jan 12, 2016
Last Verified:
Jan 1, 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:
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Tenofovir

Study Results

No Results Posted as of Jan 12, 2016