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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Atrial Fibrillation

Treatments: Drug: HGP2001; Drug: HIP2001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04764201

HM-EDOX-101

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Sequence 1

Other group

Description:

Period 1: HGP2001, Period 2: HIP2001

Treatment:

Drug: HIP2001

Drug: HGP2001

Sequence 2

Other group

Description:

Period 1: HIP2001, Period 2: HGP2001

Treatment:

Drug: HIP2001

Drug: HGP2001