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

NCT02902523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-12

No results posted yet for this study

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

Interventions

DRUG

Viread® tablet 300mg

Single dose administration(PO) in the fasted state

DRUG

HUG116 tablet 245mg

Single dose administration(PO) in the fasted state

Sponsors & Collaborators

  • Huons Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902523 on ClinicalTrials.gov