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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Viread® tablet; Drug: CKD-390

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 301-721
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (ESTIMATE): October 28, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Tenofovir Disoproxil Fumarate; Chronic Hepatitis B virus, HIV-1 infection; Healthy Male Volunteer
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: 163BE15028