A Study to Evaluate the Pharmacokinetics and Safety Betwe... | NCT07297693

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

NCT07297693

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Not yet recruiting

Last Update Posted

Dec 22, 2025Actual

Enrollment

60Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

HIP2503
HCP1306

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2025Estimated

Primary Completion Date

Mar 25, 2026Estimated

Completion Date

Apr 10, 2026Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Period1 : HCP1306 Period2 : HIP2503	Drug: HIP2503 Drug: HCP1306
Arm 2	Experimental	Period 1 : HIP2503 Period 2 : HCP1306	Drug: HIP2503 Drug: HCP1306

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIP2503	Drug	Take 1 orally disintegrating tablet once per period	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ka	Pharmacokinetic evaluation	0~72 hours
Concentration/Cmax_%	Pharmacokinetic evaluation	0~72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jee Won Shon	Contact	+82-2-410-9037		jeewon.shon@hanmi.co.kr

Overall Officials

Name	Affiliation	Role
Hee Ju Hong	H Plus Yangji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H plus Yangji Hospital		Seoul	Gwanak-gu	08779	South Korea