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

NCT04764201 | Completed Phase 1

• 1 other identifier: HM-EDOX-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUCt

  Pharmacokinetic evaluation

  0~48 hours

• Cmax

  Pharmacokinetic evaluation

  0~48 hours

Secondary Outcomes (5)

• AUCinf

  0~48 hours

• Tmax

  0~48 hours

• t1/2

  0~48 hours

• CL/F

  0~48 hours

• Vd/F

  0~48 hours

Study Arms (2)

Sequence 1

OTHER

Period 1: HGP2001, Period 2: HIP2001

Drug: HIP2001; Drug: HGP2001

Sequence 2

OTHER

Period 1: HIP2001, Period 2: HGP2001

Drug: HIP2001; Drug: HGP2001

Interventions

HIP2001 DRUG

Test drug

Sequence 1; Sequence 2

HGP2001 DRUG

Reference drug

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight \>60kg
• 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.

You may not qualify if:

• 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
• ECG QTc \>450 ms

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Jeonbuk University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingeul Kim

  Jeonbuk University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: January 16, 2021
• Primary Completion: February 26, 2021
• Study Completion: March 8, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

KR (1)