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

Study Overview
=================
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

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

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: CKD-390
* Drug: Viread® tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteer in the age of 19-45 Body weight ≥ 55kg and in the range of calculated Ideal Body Weight ± 20% Subject without a hereditary problems, chronic disease and morbid symptom Subject who sign on an informed consent form willingly Exclusion Criteria: Clinically significant disease with hepatobiliary, nephrological, gastrointestinal, respiratory, hepato-oncological, endocrine, urogenital, neurologic, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system Gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) or gastrointestinal surgery(except for appendectomy or herniotomy) Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable) The history of drug abuse or drug abuse showed a positive for urine drug test Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 1 month Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week Taking drugs have received any other investigational drug within 3 months prior to the first dosing 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 Continuously taking excessive alcohol (> 21 units/week; 1 unit = 10g of pure alcohol) or cannot stop drinking from 24 hours before admission to discharge Cigarette > 10 cigarettes a day on average for recent 3 months 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 An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Viread® tablet<br>Tenofovir Disoproxil Fumarate | Drug: Viread® tablet<br>* Tenofovir Disoproxil Fumarate 1T PO<br>|
| Experimental: CKD-390<br>Tenofovir Disoproxil Fumarate | Drug: CKD-390<br>* Tenofovir Disoproxil Aspartate 1T PO<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Tenofovir |  | 0(Pre-dose) up to 72hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | 0(Pre-dose) up to 72hr | 
| 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 | 
| Electrocardiography |  | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis B virus, HIV-1 infection, Healthy Male Volunteer, Tenofovir Disoproxil Fumarate