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

NCT ID: NCT02589457

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-12-31

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

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viread® tablet

Tenofovir Disoproxil Fumarate

Group Type: ACTIVE_COMPARATOR

Viread® tablet

Intervention Type: DRUG

Tenofovir Disoproxil Fumarate 1T PO

CKD-390

Tenofovir Disoproxil Fumarate

Group Type: EXPERIMENTAL

CKD-390

Intervention Type: DRUG

Tenofovir Disoproxil Aspartate 1T PO

Interventions

CKD-390

Tenofovir Disoproxil Aspartate 1T PO

Intervention Type: DRUG

Viread® tablet

Tenofovir Disoproxil Fumarate 1T PO

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jang Hee Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Countries

South Korea

Other Identifiers

163BE15028

Identifier Type: -

Identifier Source: org_study_id