Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers

A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Viread® tablet 300mg; Drug: HUG116 tablet 245mg

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
      • Huons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects(at screening)
• Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
• Subject without a hereditary problems, chronic disease and morbid symptom
• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

• Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
• Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
• Volunteer who had hypersensitivity reaction to medicines including Tenofovir
• Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
• Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
• Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
• Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
• Have the result of serum test(RPR Ab(VDRL), HBsAg, HCV Ab, Anti HIV(AIDS)) is a positive
• History of drug abuse, or a positive urine drug screen
• Having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
• Participation in any other clinical trial involving investigational drugs within 3 months
• Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
• Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
• Volunteers smoking over 10 cigarettes per day in the last 3 months and taking a surfeit of caffeine(caffeine>400mg per day)
• 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
• Any condition that, in the view of the investigator, would interfere with study participation

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 300mg; Tenofovir disoproxil fumarate	Drug: Viread® tablet 300mg; Single dose administration(PO) in the fasted state
EXPERIMENTAL: HUG116 tablet 245mg; Tenofovir disoproxil	Drug: HUG116 tablet 245mg; Single dose administration(PO) in the fasted state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve(AUC)last of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Maximum of concentration(Cmax) of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve(AUC)inf of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
tmax of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
t1/2β of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h
Clearance/F of Tenofovir	0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (ESTIMATE): September 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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: HUG-116 P1