A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502

Inclusion criteria

• Healthy volunteers aged between ≥20 and ≤45 years old
• Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
• Subject who voluntarily agrees to participate in this study and signs the informed consent form.

Exclusion criteria

• History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
• With symptoms indicating acute illness within 28 days prior to the first IP administration.
• Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
• Any clinically significant activity of chronic medical illness.
• History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
• Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
• Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration.
• Inability to take standard hospital diet.
• Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration.
• Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
• Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
• Any use of tobacco or nicotine within three months.
• Subjects rejected to use clinically effective contraceptive methods during the study period.
• Subjects having been deemed inappropriate for the trial as determined by the investigator.