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

Huons

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: HUG116 tablet 245mg

Drug: Viread® tablet 300mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02902523

HUG-116 P1

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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