Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers

Study Overview
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Brief Summary
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This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.

Official Title
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A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Viread 300mg
* Drug: DA-2802 319mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 to 50, healthy male subjects(at screening) Body weight over 55kg, BMI between 18.0 - 27.0 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 including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder) Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics exceed 1.5 times the normal range of AST, ALT at screening test before randomization 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 or who cannot abstain from smoking during the study(from 24hr before admission to discharge) Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods Volunteers who are not using adequate contraception methods or have a pregnancy plan volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study any condition that, in the view of the investigator, would interfere with study participation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Viread → DA-2802<br>Viread 300mg(Tenofovir disoproxil fumarate) DA-2802 319mg(Tenofovir disoproxil orotate) | Drug: Viread 300mg<br>* single dose administration after 10hr fasting<br>* Other names: Tenofovir disoproxil fumarate;Drug: DA-2802 319mg<br>* single dose administration after 10hr fasting<br>* Other names: Tenofovir disoproxil orotate;|
| Experimental: DA-2802 → Viread<br>Viread 300mg(Tenofovir disoproxil fumarate) DA-2802 319mg(Tenofovir disoproxil orotate) | Drug: Viread 300mg<br>* single dose administration after 10hr fasting<br>* Other names: Tenofovir disoproxil fumarate;Drug: DA-2802 319mg<br>* single dose administration after 10hr fasting<br>* Other names: Tenofovir disoproxil orotate;|

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 admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 
| Maximum of concentration(Cmax) of Tenofovir |  | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum concentration(Tmax) of Tenofovir |  | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 
| Terminal half-life(t1/2) of Tenofovir |  | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 
| Apparent Clearance(CL/F) of Tenofovir |  | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 
| Area Under Curve(AUC)inf of Tenofovir |  | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B