Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

Study Overview
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Brief Summary
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This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects

Detailed Description
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To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Official Title
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A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Vemlidy Tab
* Drug: DA-2803 Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening. Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2 BMI = Weight(kg)/ Height(m)2 Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial Exclusion Criteria: History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder. Any medical history that may affect drug absorption, distribution, metabolism and excretion. Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) Any clinically significant chronic medical illness. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Individuals with one of the following laboratory test results in screening. AST, ALT > UNL (upper normal limit) x 1.5 Creatinine clearance ≤ 60 mL/min Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL. Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration. Individuals who cannot eat standard meal provided from clinical trial center. Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration. Individuals who had received a blood transfusion within 60 days prior to study drug administration. Exposure to any investigational drug within 6 months prior to the first IP administration. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration. Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening. Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening. Subjects having been deemed inappropriate for the trial as determined by the investigator.

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

Sexes Eligible for Study
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All

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: Reference-Test<br> | Drug: Vemlidy Tab<br>* 1T<br>* Other names: Reference;Drug: DA-2803 Tab<br>* 1T<br>* Other names: Test;|
| Experimental: Test-Reference<br> | Drug: Vemlidy Tab<br>* 1T<br>* Other names: Reference;Drug: DA-2803 Tab<br>* 1T<br>* Other names: Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of DA-2803, Vemlidy | Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final | pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour | 
| Cmax of DA-2803, Vemlidy | The maximum DA-2803/Vemlidy concentration in blood sampling time t | pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour |