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

• Status: Completed
• Trial end date: 2021-03-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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