A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers

April 11, 2024 updated by: Hanmi Pharmaceutical Company Limited

A Randomized, Open Label, Single Dose, Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2303 and Co-administration of RLD2302 and RLD2102 in Healthy Volunteers Under Fasting Conditions

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

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 Contact

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of
        • Jeonbuk University Hospital
        • Principal Investigator:
          • Min-gul Kim, MD
        • Contact:
          • Jin A Lee, Researcher
          • Phone Number: 063-259-3550

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 19~54 years in healthy volunteers
  • 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 90 mmHg ≤ sitSBP <140 mmHg, 50 mmHg ≤ sitDBP <90 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
  • Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

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
Experimental: Arm 1
  • Period1 : RLD2302 + RLD2102
  • Period2 : HCP2303
Drug: HCP2303
Take 1 tablet once per period
Drug: RLD2302
Take 1 tablet once per period
Drug: RLD2102
Take 1 tablet once per period
Experimental: Arm 2
  • Period1 : HCP2303
  • Period2 : RLD2302 + RLD2102
Drug: HCP2303
Take 1 tablet once per period
Drug: RLD2302
Take 1 tablet once per period
Drug: RLD2102
Take 1 tablet once per period

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: Min-gul Kim, MD, Jeonbuk National 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 (Estimated)

April 30, 2024

Primary Completion (Estimated)

June 8, 2024

Study Completion (Estimated)

June 8, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HM-EMMA-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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