A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers

December 9, 2025 updated by: Hanmi Pharmaceutical Company Limited

An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Subjects

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

  • South Korea
    • Gwanak-gu
      • Seoul, Gwanak-gu, South Korea, 08779
        • H plus Yangji Hospital
        • Contact:
          • Eun Jung Lee Project Manager
          • Phone Number: +82-70-4665-9479
          • Email: m3202@newyjh.com
        • Principal Investigator:
          • Hee Ju Hong

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 19~64 years in healthy volunteers
  • 18 kg/m^2 ≤ BMI ≤ 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
  • 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 14 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
  • 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 : HCP1306
  • Period2 : HIP2503
Drug: HIP2503
Take 1 orally disintegrating tablet once per period
Drug: HCP1306
Take 1 tablet once per period
Experimental: Arm 2
  • Period 1 : HIP2503
  • Period 2 : HCP1306
Drug: HIP2503
Take 1 orally disintegrating tablet once per period
Drug: HCP1306
Take 1 tablet once per period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
Cmax
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
Tmax
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
t1/2
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
Ka
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
Concentration/Cmax_%
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 hours
AUCt/AUCinf
Time Frame: 0~72 hours
Pharmacokinetic evaluation
0~72 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: Hee Ju Hong, H plus Yangji 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)

December 19, 2025

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HM-RIZE-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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