Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
NCT ID: NCT03826485
Last Updated: 2019-02-01
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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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2019-04-01
2019-07-31
Brief Summary
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Detailed Description
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2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A group
Period 1: PRIC Period 2: Pranlukast hydrate
PRIC
Pranlukast hydrate 50mg
Pranlukast hydrate
Pranlukast hydrate 225mg/2.25g
B group
Period 1: Pranlukast hydrate Period 2: PRIC
PRIC
Pranlukast hydrate 50mg
Pranlukast hydrate
Pranlukast hydrate 225mg/2.25g
Interventions
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PRIC
Pranlukast hydrate 50mg
Pranlukast hydrate
Pranlukast hydrate 225mg/2.25g
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
Exclusion Criteria
* Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
19 Years
40 Years
MALE
Yes
Sponsors
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SamA Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Facility Contacts
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Hyung Suk Lim, MD, Ph.D.
Role: primary
Other Identifiers
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PRIC
Identifier Type: -
Identifier Source: org_study_id
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