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

March 30, 2021 updated by: Hanmi Pharmaceutical Company Limited

A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1
Period 1: HGP2001, Period 2: HIP2001
Drug: HIP2001
Test drug
Drug: HGP2001
Reference drug
Other: Sequence 2
Period 1: HIP2001, Period 2: HGP2001
Drug: HIP2001
Test drug
Drug: HGP2001
Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours
Cmax
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours
Tmax
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours
t1/2
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours
CL/F
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours
Vd/F
Time Frame: 0~48 hours
Pharmacokinetic evaluation
0~48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Mingeul Kim, Jeonbuk University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2021

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-EDOX-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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