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

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

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

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.

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.