Clinical trial NCT02589457: Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet With Viread® Tablet
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B virus, HIV-1 infection
Healthy Male Volunteer
Tenofovir Disoproxil Fumarate
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: AUCt of Tenofovir
timeFrame: 0(Pre-dose) up to 72hr
Secondary outcomes:
measure: AUCinf
timeFrame: 0(Pre-dose) up to 72hr
measure: Blood pressure
timeFrame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
measure: tmax
timeFrame: 0(Pre-dose) up to 72hr
measure: t1/2β
timeFrame: 0(Pre-dose) up to 72hr
measure: Clearance/F
timeFrame: 0(Pre-dose) up to 72hr
measure: Electrocardiography
timeFrame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
measure: Physical Examination
timeFrame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
measure: Pulse rate
timeFrame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
measure: Temperature
timeFrame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
Study officials:
affiliation: Chungnam National University Hospital
name: Jang Hee Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: