The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

This is an interventional treatment trial for Atrial Fibrillation Read More

Inclusion Criteria:

• 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
• 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
• agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

Exclusion Criteria:

• A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
• A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
• A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
• Positive results of serological tests
• Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
• Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
• Have drank more than 210 g/week of alcohol within 30 days before the screening date
• Have smoked more than 10 bills/day within 30 days before the screening date
• AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec
• 12-ECG QTc >450 ms