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

NCT ID: NCT04764201

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-16
• Study Completion Date: 2021-03-08

Brief Summary

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

Period 1: HGP2001, Period 2: HIP2001

Group Type: OTHER

HIP2001

Intervention Type: DRUG

Test drug

HGP2001

Intervention Type: DRUG

Reference drug

Sequence 2

Period 1: HIP2001, Period 2: HGP2001

Group Type: OTHER

HIP2001

Intervention Type: DRUG

Test drug

HGP2001

Intervention Type: DRUG

Reference drug

Interventions

HIP2001

Test drug

Intervention Type: DRUG

HGP2001

Reference drug

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingeul Kim

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk University Hospital

Locations

Jeonbuk University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

HM-EDOX-101

Identifier Type: -

Identifier Source: org_study_id