HDDO-1614 Bio Equivalence Study

This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).

Inclusion criteria

• Body weight 50kg ≤ / BMI=18~29kg/㎡
• A person who is determined to be eligible for the test through a physical examination or an interview
• Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, and serology test

Exclusion criteria

• Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
• Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
• Any person who shows any of the following results in the screening test

• AST or ALT > 2 times upper limit of normal range
• Total Bilirubin > 2.0mg/dL
• Glomerular filtration Rate(eGFR) < 60mL/min/1.7㎡
• Those who show signs of hypotension (systolic blood pressure ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
• Those who have a history of drug or who have a positive urine drug test