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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Huons Co., Ltd.; Huons Co.,Ltd.
• Treatments: Tenofovir

Criteria

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