NCT07297693

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 19, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Pharmacokinetic evaluation

    0~72 hours

  • Cmax

    Pharmacokinetic evaluation

    0~72 hours

Secondary Outcomes (6)

  • Ka

    0~72 hours

  • Concentration/Cmax_%

    0~72 hours

  • AUCinf

    0~72 hours

  • AUCt/AUCinf

    0~72 hours

  • Tmax

    0~72 hours

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

* Period1 : HCP1306 * Period2 : HIP2503

Drug: HIP2503Drug: HCP1306

Arm 2

EXPERIMENTAL

* Period 1 : HIP2503 * Period 2 : HCP1306

Drug: HIP2503Drug: HCP1306

Interventions

HIP2503DRUG

Take 1 orally disintegrating tablet once per period

Arm 1Arm 2
HCP1306DRUG

Take 1 tablet once per period

Arm 1Arm 2

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19\~64 years in healthy volunteers
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

Study Officials

  • Hee Ju Hong

    H Plus Yangji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee Won Shon

CONTACT

+82-2-410-9037jeewon.shon@hanmi.co.kr

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

December 9, 2025

First Posted

December 22, 2025

Study Start

December 19, 2025

Primary Completion

March 25, 2026

Study Completion

April 10, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

KR(1)