A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
NCT ID: NCT06518122
Last Updated: 2025-02-20
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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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2024-09-01
2025-01-03
Brief Summary
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Detailed Description
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\[PART B\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
\[PART B\] Single Arm (Three periods)
TREATMENT
NONE
Study Groups
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[PART A] Sequence 1
Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART A] Sequence 2
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART A] Sequence 3
Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART A] Sequence 4
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART A] Sequence 5
Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART A] Sequence 6
Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
[PART B] Single arm
Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
RLD2102
Take it once a day per period
Interventions
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HCP1306
Take it once a day per period.
RLD2302
Take it once a day per period.
RLD2102
Take it once a day per period
Eligibility Criteria
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Inclusion Criteria
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<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
* Subjects who judged ineligible by the investigator
19 Years
54 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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Min-gul Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Jeonbuk National University Hospital
Locations
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Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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HM-ROEM-101
Identifier Type: -
Identifier Source: org_study_id
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