Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B virus, HIV-1 infection, Healthy Male Volunteer, Tenofovir Disoproxil Fumarate
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.
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
Interventions
DRUGCKD-390
Tenofovir Disoproxil Aspartate 1T PO
DRUGViread® tablet
Tenofovir Disoproxil Fumarate 1T PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt of Tenofovir | 0(Pre-dose) up to 72hr |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| tmax | 0(Pre-dose) up to 72hr |
| t1/2β | 0(Pre-dose) up to 72hr |
| Clearance/F | 0(Pre-dose) up to 72hr |
| AUCinf | 0(Pre-dose) up to 72hr |
| Physical Examination | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Pulse rate | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Temperature | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Electrocardiography | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
Countries
South Korea
Outcome results
None listed