A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean Volunteers

40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.

Inclusion criteria

• Healthy adult volunteers aged ≥ 19 years
• Male for body weight ≥50 kg, female for body weight ≥45 kg
• Calculated body mass index (BMI) of 18 to 30 kg/m2
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• Those who agrees to exclude the possibility of pregnancy by using a medically accepted method of contraception from the first administration of investigational medicine to 7 days after the last administration of investigational medicine

Exclusion criteria

• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
• Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.

• Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
• Patients with the following diseases

• Patients with known hypersensitivity reactions such as anaphylaxis or angioedema to investigational drugs and components
• Patients with pancreatitis
• Patients with heart failure or a history of heart failure
• Patients with active bladder cancer or a history of bladder cancer
• Patients with hepatic impairment
• Patients with severe renal impairment
• Patients with diabetic ketoacidosis, diabetic coma and pre-coma, patients with type 1 diabetes
• Before and after surgery, patients with severe infections, patients with severe trauma
• Patients with gross hematuria not investigated
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Those who are deemed insufficient to participate in this clinical trial by investigators.
• Woman who are pregnant or breastfeeding.
• Those who have a history of clinically significant mental illness