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

NCT02902523 | Completed Phase 1

• 1 other identifier: HUG-116 P1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Viread ® tablet 300mg

ACTIVE COMPARATOR

Tenofovir disoproxil fumarate

Drug: Viread® tablet 300mg

HUG116 tablet 245mg

EXPERIMENTAL

Tenofovir disoproxil

Drug: HUG116 tablet 245mg

Interventions

Viread® tablet 300mg DRUG

Single dose administration(PO) in the fasted state

Viread ® tablet 300mg

HUG116 tablet 245mg DRUG

Single dose administration(PO) in the fasted state

HUG116 tablet 245mg

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Seongnam-si, Gyeonggi-do, 13486, South Korea

Location

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

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

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: September 12, 2016
• First Posted: September 15, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

KR (1)