A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
NCT ID: NCT02072213
Last Updated: 2019-01-10
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
36 participants
INTERVENTIONAL
2013-08-31
2014-01-31
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
BASIC_SCIENCE
NONE
Study Groups
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GL2702 GLARS-NF1 , fasted
Tamsulsoin 0.4mg
GL2702 GLARS-NF1
0.4mg once a day
Omix Ocas® , fasted
Tamsulsoin 0.4mg
Omix Ocas
0.4mg once a day
GL2702 GLARS-NF1, after meal
Tamsulsoin 0.4mg
GL2702 GLARS-NF1
0.4mg once a day
Omix Ocas®, after meal
Tamsulsoin 0.4mg
Omix Ocas
0.4mg once a day
Interventions
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GL2702 GLARS-NF1
0.4mg once a day
Omix Ocas
0.4mg once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%
Exclusion Criteria
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* CPK \> 2 times (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg
20 Years
45 Years
MALE
Yes
Sponsors
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GL Pharm Tech Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Min-Gul Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Chonbuk National University Hospital
Jeonju, Jeollabukdo, South Korea
Countries
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Other Identifiers
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GL2702-103
Identifier Type: -
Identifier Source: org_study_id
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