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

NCT02589457 | Completed Phase 1

• 1 other identifier: 163BE15028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B virus, HIV-1 infection; Healthy Male Volunteer; Tenofovir Disoproxil Fumarate

Outcome Measures

Primary Outcomes (1)

• AUCt of Tenofovir

  0(Pre-dose) up to 72hr

Secondary Outcomes (9)

• 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

Study Arms (2)

Viread® tablet

ACTIVE COMPARATOR

Tenofovir Disoproxil Fumarate

Drug: Viread® tablet

CKD-390

EXPERIMENTAL

Tenofovir Disoproxil Fumarate

Drug: CKD-390

Interventions

CKD-390 DRUG

Tenofovir Disoproxil Aspartate 1T PO

CKD-390

Viread® tablet DRUG

Tenofovir Disoproxil Fumarate 1T PO

Viread® tablet

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Jung-gu, 301-721, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jang Hee Hong, MD, PhD

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

KR (1)