Pharmacokinetics and Safety of HCP1105 and Co-administration of HGP0918, HGP0816 in Healthy Male Volunteers
NCT ID: NCT02941796
Last Updated: 2016-10-21
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
68 participants
INTERVENTIONAL
2016-06-30
2016-10-31
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
T → R
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
HCP1105
HCP0918
HCP0816
Sequence 2
R → T
T : HCP1105 4cap R : HGP0918 4cap + HGP0816 4tab
HCP1105
HCP0918
HCP0816
Interventions
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HCP1105
HCP0918
HCP0816
Eligibility Criteria
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Inclusion Criteria
* Healthy male volunteers, aged 19 to 55 years.
* The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
Exclusion Criteria
* Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
* Somenone has a declined kidney function and his eGFR \< 60mL/min/1.73m2
19 Years
55 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Inje University Busan Paik Hospital
Busan, , South Korea
Countries
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Other Identifiers
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HM-ROMA-106
Identifier Type: -
Identifier Source: org_study_id
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