A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.
NCT ID: NCT04084197
Last Updated: 2019-09-10
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
61 participants
INTERVENTIONAL
2018-12-19
2019-01-04
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
Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
HIP1402
Tamsulosin (HanmiTams Capsule) 0.4mg
HIP1801
Tamsulosin 0.4mg
Sequence 2
Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
HIP1402
Tamsulosin (HanmiTams Capsule) 0.4mg
HIP1801
Tamsulosin 0.4mg
Sequence 3
High fat diet + HIP1402, Period 2 : High fat diet + HIP1801
HIP1402
Tamsulosin (HanmiTams Capsule) 0.4mg
HIP1801
Tamsulosin 0.4mg
Sequence 4
High fat diet + HIP1801, Period 2 : High fat diet + HIP1402
HIP1402
Tamsulosin (HanmiTams Capsule) 0.4mg
HIP1801
Tamsulosin 0.4mg
Interventions
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HIP1402
Tamsulosin (HanmiTams Capsule) 0.4mg
HIP1801
Tamsulosin 0.4mg
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 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
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-TOD-101
Identifier Type: -
Identifier Source: org_study_id
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