A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.
NCT ID: NCT05191563
Last Updated: 2022-01-13
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
56 participants
INTERVENTIONAL
2021-07-31
2021-09-12
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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Sequence 1 (Reference-Test)
Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1
HCP1904-1
Take it once per period.
RLD2006
Take it once per period.
RLD2001-2
Take it once per period.
Sequence 2 (Test-Reference)
Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006
HCP1904-1
Take it once per period.
RLD2006
Take it once per period.
RLD2001-2
Take it once per period.
Interventions
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HCP1904-1
Take it once per period.
RLD2006
Take it once per period.
RLD2001-2
Take it once per period.
Eligibility Criteria
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Inclusion Criteria
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria
2. Subjects who judged ineligible by the investigator
19 Years
45 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Yangji Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-CHOURS-101
Identifier Type: -
Identifier Source: org_study_id
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