A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers
NCT ID: NCT07297693
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-12-19
2026-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1
* Period1 : HCP1306
* Period2 : HIP2503
HIP2503
Take 1 orally disintegrating tablet once per period
HCP1306
Take 1 tablet once per period
Arm 2
* Period 1 : HIP2503
* Period 2 : HCP1306
HIP2503
Take 1 orally disintegrating tablet once per period
HCP1306
Take 1 tablet once per period
Interventions
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HIP2503
Take 1 orally disintegrating tablet once per period
HCP1306
Take 1 tablet once per period
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects who judged ineligible by the investigator
19 Years
64 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hee Ju Hong
Role: PRINCIPAL_INVESTIGATOR
H Plus Yangji Hospital
Locations
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H plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Eun Jung Lee Project Manager
Role: primary
Other Identifiers
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HM-RIZE-101
Identifier Type: -
Identifier Source: org_study_id