HDDO-1614 Bio Equivalence Study

A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects

A randomized, open-label, single-dose, crossover 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

  1. AST or ALT > 2 times upper limit of normal range
  2. Total Bilirubin > 2.0mg/dL
  3. 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