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

Study Overview
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Brief Summary
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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
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Healthy

Intervention / Treatment
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* Drug: Viread® tablet 300mg
* Drug: HUG116 tablet 245mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Viread ® tablet 300mg<br>Tenofovir disoproxil fumarate | Drug: Viread® tablet 300mg<br>* Single dose administration(PO) in the fasted state<br>|
| Experimental: HUG116 tablet 245mg<br>Tenofovir disoproxil | Drug: HUG116 tablet 245mg<br>* Single dose administration(PO) in the fasted state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |